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1. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Tomczak, Piotr, Choueiri, Toni, Park, Se Hoon, Venugopal, Balaji, Ferguson, Thomas R., Hajek, Jaroslav, Lin, Tzu-Ping, Symeonides, Stefan N., Lee, Jae Lyun, Sawrycki, Piotr, Haas, Naomi B., Gurney, Howard P., Mahave, Mauricio, Sarwar, Naveed, Thiery-Vuillemin, Antoine, Gross-Goupil, Marine, Chevreau, Christine, Burke, John M., Doshi, Gurjyot, Melichar, Bohuslav, Topart, Delphine, Oudard, Stephane, Kopyltsov, Evgeniy, Hammers, Hans-Joerg, Quinn, David I., Alva, Ajjai, Menezes, Juliana de Janoski, Silva, Adriano Goncalves e, Winquist, Eric W., Hamzaj, Alketa, Procopio, Giuseppe, Karaszewska, Boguslawa, Nowakowska-Zajdel, Ewa M., Alekseev, Boris Y., Gafanov, Rustem A., Izmailov, Adel, Semenov, Andrey, Afanasyev, Sergey G., Lipatov, Oleg N., Powles, Thomas B., Srinivas, Sandy, McDermott, David, Kochuparambil, Samith T., Davis, Ian D., Peltola, Katriina, Sabbatini, Roberto, Chung, Jinsoo, Shkolnik, Michail I., Matveev, Vsevolod B., Gajate Borau, Pablo, McCune, Steven, Hutson, Thomas E., Dri, Alejandro, Sales, Silvio Correia, Yeung, Carrie, Alcala Castro, Carmen Marcela, Bostrom, Peter, Laguerre, Brigitte, Buttigliero, Consuelo, de Giorgi, Ugo, Fomin, Eugeniy A., Zakharia, Yousef, Hwang, Clara, Singer, Eric A., Yorio, Jeffrey T., Waterhouse, David, Kowalyszyn, Ruben Dario, Alfie, Margarita Sonia, Yanez Ruiz, Eduardo, Buchler, Tomas, Kankaanranta, Krista, Ferretti, Gianluigi, Kimura, Go, Nishimura, Kazuo, Masumori, Naoya, Tamada, Satoshi, Kato, Haruaki, Kitamura, Hiroshi, Danielewicz, Iwona, Wojcik-Tomaszewska, Joanna, Sala Gonzalez, Nuria, Chiu, Kun-Yuan, Atkins, Michael B., Heath, Elisabeth, Rojas-Uribe, Gustavo Adolfo, Gonzalez Fernandez, Manuel Enrique, Feyerabend, Susan, Pignata, Sandro, Numakura, Kazuyuki, Cybulska Stopa, Bozena, Zukov, Ruslan, Climent Duran, Miguel Angel, Maroto Rey, Pablo Jose, Montesa Pino, Alvaro, Chang, Chao-Hsiang, Vengalil, Salil, Waddell, Tom S., Cobb, Patrick W., Hauke, Ralph, Anderson, Daniel M., Sarantopoulos, John, Gourdin, Theodore, Zhang, Tian, Jayram, Gautam, Fein, Luis Enrique, Harris, Carole, Beato, Patricia Medeiros Milhomem, Flores, Francisco, Estay, Angela, Rubiano, Juan Andres, Bedke, Jens, Hauser, Stefan, Neisius, Andreas, Busch, Jonas, Anai, Satoshi, Tsunemori, Hiroyuki, Sawka, Dariusz, Sikora-Kupis, Bozena, Arranz, Jose Angel, Delgado, Ignacio, Chen, Chung-Hsin, Gunderson, Elizabeth, Tykodi, Scott, Koletsky, Alan, Chen, Kevin, Agrawal, Manish, Kaen, Diego Lucas, Sade, Juan Pablo, Tatangelo, Marcelo Daniel, Parnis, Francis, Barbosa, Fernando Maciel, Faucher, Genevieve, Iqbal, Nayyer, Marceau, Daniele, Paradis, Jean-Benoit, Hanna, Nawar, Acevedo, Alejandro, Ibanez, Carolina, Villanueva, Luis, Galaz, Pedro Pablo, Durango, Isabel Cristina, Manneh, Ray, Kral, Zdenek, Holeckova, Petra, Hakkarainen, Heikki, Ronkainen, Hanna, Abadie-Lacourtoisie, Sophie, Tartas, Sophie, Goebell, Peter J., Grimm, Marc-Oliver, Hoefner, Thomas, Wirth, Manfred, Panic, Andrej, Schultze-Seemann, Wolfgang, Yokomizo, Akira, Mizuno, Ryuichi, Uemura, Hirotsugu, Eto, Masatoshi, Tsujihata, Masao, Matsukawa, Yoshihisa, Murakami, Yoji, Kim, Miso, Hamberg, Paul, Marczewska-Skrodzka, Malgorzata, Szczylik, Cezary, Humphreys, Alison C., Jiang, Peter, Kumar, Birendra, Lu, Gary, Desai, Arpita, Karam, Jose Antonio, Keogh, George, Fleming, Mark, Zarba, Juan Jose, Leiva, Viviana E., Mendez, Guillermo Ariel, Harris, Samuel J., Brown, Stephen J., Antonio Junior, Joao Neif, Costamilan, Rita de Cassia, Rocha, Roberto Odebrecht, Muniz, David, Brust, Leandro, Lalani, Aly-Khan, Graham, Jeffrey, Levesque, Michael, Orlandi, Francisco, Kotasek, Rostislav, Deville, Jean L., Borchiellini, Delphine, Merseburger, Axel, Rink, Michael, Roos, Frederik, McDermott, Ray, Oyama, Masafumi, Yamamoto, Yoshiaki, Tomita, Yoshihiko, Miura, Yuji, Ioritani, Naomasa, Westgeest, Hans, Kubiatowski, Tomasz, Bal, Wieslaw, Girones Sarrio, Regina, Rowe, Julie, Prow, Debra M., Senecal, Francis, Hashemi-Sadraei, Neda, Cole, Scott W., Kendall, Stephan D., Richards, Donald A., Schnadig, Ian D., Gupta, Mukul, Powles, Thomas, Ferguson, Thomas, Symeonides, Stefan N, Gurney, Howard, Chang, Yen-Hwa, Haas, Naomi B, Burgents, Joseph E, Xu, Lei, Imai, Kentaro, Quinn, David I, and Choueiri, Toni K

Published
2022
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2. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study

Author

Necchi, Andrea, Loriot, Yohann, Park, Se Hoon, Tagawa, Scott, Flechon, Aude, Alexeev, Boris, Varlamov, Sergey, Huddart, Robert, Burgess, Earle, Rezazadeh, Arash, Siefker-Radtke, Arlene, Vano, Yann, Gasparro, Donatello, Hamzaj, Alketa, Kopyltsov, Eugeniy, Gracia Donas, Jesus, Mellado, Begona, Parikh, Omi, Schatteman, Peter, Culine, Stephane, Houédé, Nadine, Zanetta, Sylvie, Facchini, Gaetano, Scagliotti, Giorgio, Schinzari, Giovanni, Lee, Jae Lyun, Shkolnik, Mikhail, Fleming, Mark, Joshi, Monica, O'Donnell, Peter, Stöger, Herbert, Decaestecker, Karel, Dirix, Luc, Machiels, Jean Pascal, Borchiellini, Dephine, Delva, Remy, Rolland, Frederic, Hadaschik, Boris, Retz, Margitta, Rosenbaum, Eli, Basso, Umberto, Mosca, Alessandra, Lee, Hyo Jin, Shin, Dong Bok, Cebotaru, Cristina, Duran, Ignacio, Moreno, Victor, Perez Gracia, Jose Luis, Pinto, Alvaro, Su, Wen-Pin, Wang, Shian-Shiang, Hainsworth, John, Schnadig, Ian, Srinivas, Sandhya, Vogelzang, Nicholas, Loidl, Wolfgang, Meran, Johannes, Gross Goupil, Marine, Joly, Florence, Imkamp, Florian, Klotz, Theodor, Krege, Susanne, May, Matthias, Schultze-Seemann, Wolfgang, Strauss, Arne, Zimmermann, Uwe, Keizman, Daniel, Peer, Avivit, Sella, Avishai, Berardi, Rossana, De Giorgi, Ugo, Sternberg, Cora Nanette, Rha, Sun Young, Bulat, Iurie, Izmailov, Adel, Matveev, Vsevolod, Vladimirov, Vladimir, Carles, Joan, Font, Albert, Saez, Maribel, Syndikus, Isabel, Tarver, Kathryn, Appleman, Leonard, Burke, John, Dawson, Nancy, Jain, Sharad, Zakharia, Yousef, Siefker-Radtke, Arlene O, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle F, Fleming, Mark T, Rezazadeh Kalebasty, Arash, Mellado, Begoña, Varlamov, Sergei, Joshi, Monika, Tagawa, Scott T, Akapame, Sydney, Santiago-Walker, Ademi E, Monga, Manish, and O'Hagan, Anne

Published
2022
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3. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Cascallar, Diana Vera, Varela, Mirta, Lazzaro, Mauricio Fernandez, Kaen, Diego Lucas, Gatica, Gabriela, Flores, David Hugo, Falco, Agustin, Molina, Matias, Van Aelst, Filip, Vulsteke, Christof, Sautois, Brieuc, Machiels, Jean-Pascal, Schallier, Denis, Brust, Leandro, Rapatoni, Liane, Azevedo, Sergio J, Marinho, Gisele, Soares, Joao Paulo Holanda, Dzik, Carlos, Almeida Silva, Jamile, Fay, Andre Poisl, Gingerich, Joel, Fradet, Yves, Ferrario, Cristiano, Potvin, Kylea, Vanhuyse, Marie, Abdelsalam, Mahmoud, Cheng, Susanna, Caglevic, Christian, Reyes, Felipe, Leal, Jose Luis, Francisco, Francisco, Ibanez, Carolina, Joly, Florence, Laguerre, Brigitte, Ladoire, Sylvain, Flechon, Aude, Topart, Delphine, Huillard, Olivier, Oudard, Stéphane, Gross-Goupil, Marine, Culine, Stephane, Loriot, Yohann, Gravis, Gwenaelle, Reichardt, Peter, Retz, Margitta, Herden, Jan, Pfister, David, Ohlman, Carsten, Stoeckle, Michael, Wirth, Manfred, Lorch, Anja, Niegisch, Guenter, Goebell, Peter J, Boegemann, Martin, Merseburger, Axel, Gakis, Georgios, Bedke, Jens, Neisius, Andreas, Thomas, Christian, Hoefner, Thomas, Telekes, Andras, Kosa, Judit Erzsebet, Revesz, Janos, Bodoky, Gyorgy, Csoszi, Tibor, Csejtei, Andras, Geczi, Lajos, Ruzsa, Agnes, Kolonics, Zsuzsanna, Erfan, Jozsef, McDermott, Ray, Bambury, Richard, Sella, Avishay, Frank, Stephen Jay, Kejzman, Daniel, Goldman, Olesya, Rosenbaum, Eli, Peer, Avivit, Berger, Raanan, Rouvinov, Keren, Sarid, David, Fukasawa, Satoshi, Arai, Gaku, Yamaguchi, Akito, Yokomizo, Akira, Takayama, Tatsuya, Kinoshita, Hidefumi, Kikuchi, Eiji, Mizuno, Ryuichi, Fujii, Yasuhisa, Sassa, Naoto, Matsukawa, Yoshihisa, Fujimoto, Kiyohide, Matsubara, Nobuaki, Tanikawa, Toshiki, Tomita, Yoshihiko, Nishimura, Kazuo, Tsujihata, Masao, Oyama, Masafumi, Masumori, Naoya, Kanayama, Hiroomi, Takano, Toshimi, Miura, Yuji, Miyazaki, Jun, Joraku, Akira, Kimura, Tomokazu, Yamamoto, Yoshiaki, Kobayashi, Kazuki, De Wit, Ronald, Aarts, Maureen, Gerritsen, Winald, Los, Maartje, Beerepoot, Laurens, Izmailov, Adel, Gorelov, Sergey Igorevich, Alekseev, Boris Yakovlevich, Semenov, Andrey, Kostorov, Vladimir Anatolyevich, Alekseev, Sergey M, Zyryanov, Alexander, Oschepkov, Vasiliy Nikolaevich, Shidin, Vladimir Aleksandrovich, Vladimirov, Vladimir Ivanovich, Gafanov, Rustem Airatovich, Karlov, Petr Alexandrovich, Anderson, David Brian, Shepherd, Lucinda, Cohen, Graham Lawrence, Rapoport, Bernardo Louis, Ruff, Paul, Lee, Nari, Bae, Woo Kyun, Lee, Hyo Jin, Herranz, Urbano Anido, Rodriguez-Vida, Alejo, Morales Barrera, Rafael, Grande, Enrique, Alonso Gordoa, Teresa, Guma Padro, Josep, Gauna, Daniel Castellano, Arranz, Jose Angel, Munoz Langa, Jose, Sarrio, Regina Girones, Montesa Pino, Alvaro, Juan Fita, Maria Jose, Su, Yu-Li, Lin, Yung-Chang, Su, Wen-Pin, Shen, Ying-Chun, Chang, Yen-Hwa, Huang, Yi-Hsiu, Sriuranpong, Virote, Chansriwong, Phichai, Srimuninnimit, Vichien, Danchaivijitr, Pongwut, Abali, Huseyin, Yavuz, Sinan, Ozyilkan, Ozgur, Sendur, Mehmet Ali Nahit, Ekenel, Meltem, Ozguroglu, Mustafa, Arslan, Cagatay, Gunduz, Seyda, Ozdogan, Mustafa, Birtle, Alison, Powles, Thomas, Huddart, Robert, de Santis, Maria, Zarkar, Anjali, Evans, Linda, Hussain, Syed, DiSimone, Christopher, Muina, Antonio F, Schlegel, Peter, Jhangiani, Haresh S, Harrison, Michael, Slater, Dennis E, Wright, David, Percent, Ivor J, Lin, Jianqing, Hwang, Clara, Mamtani, Ronac, Gupta, Sumati, Bajaj, Madhuri, Galamaga, Robert, Eklund, John, Wallace, James, Shtivelband, Mikhail, Suh, Jason Jung-Gon, Burhani, Nafisa, Eadens, Matthew, Gunturu, Krishna, Burgess, Earle, Wong, John, Chaudhry, Arvind, Van Veldhuizen, Peter, Graff, Stephanie, Thomas, Christian A, Schnadig, Ian D, Carneiro, Benedito, Hussain, Maha, Morgans, Alicia, Fitzharris, John T, Oliff, Ira A, Vuky, Jacqueline, Hauke, Ralph, Baron, Ari, Joshi, Monika, Bolemon, Britt H, Jiang, Peter, Mega, Anthony E, Markus, Maurice, Pfanzelter, Nicklas, Lawler, William Eyre, Cobb, Patrick Wayne, Courtright, Jay G, Jain, Sharad, Doshi, Gurjyot, Gunuganti, Vijay K, Sartor, Oliver Alton, Cole, Scott W, Babiker, Hani, Uchio, Edward M, Drakaki, Alexandra, Mannuel, Heather D, Alva, Ajjai, Guancial, Elizabeth, Fung, Chunkit, Charles, Anthony, Amato, Robert J, Arriaga, Yull, Bowman, Isaac, Ades, Steven, Dreicer, Robert, Yu, Evan, Quinn, David I, Fleming, Mark, Csőszi, Tibor, Özgüroğlu, Mustafa, Géczi, Lajos, Cheng, Susanna Y-S, Oudard, Stephane, Fléchon, Aude, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, and Homet Moreno, Blanca

Published
2021
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4. Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study

Author

McFarlane, Joshua J., Kochenderfer, Mark D., Olsen, Mark R., Bauer, Todd M., Molina, Ana, Hauke, Ralph J., Reeves, James A., Babu, Sunil, Van Veldhuizen, Peter, Somer, Bradley, Gunuganti, Vijay, Schnadig, Ian, George, Saby, Page, Ray D., Arrowsmith, Edward, Jain, Rohit K., Zhang, Joshua, McHenry, M. Brent, Johansen, Jennifer L., and Vogelzang, Nicholas J.

Published
2020
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5. Safety and Efficacy of Nivolumab in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study

Author

Vogelzang, Nicholas J., Olsen, Mark R., McFarlane, Joshua J., Arrowsmith, Edward, Bauer, Todd M., Jain, Rohit K., Somer, Bradley, Lam, Elaine T., Kochenderfer, Mark D., Molina, Ana, Doshi, Gurjyot, Lingerfelt, Brian, Hauke, Ralph J., Gunuganti, Vijay, Schnadig, Ian, Van Veldhuizen, Peter, Fleming, Mark, Galamaga, Robert, Gupta, Mukul, Hool, Hugo, Hutson, Thomas, Zhang, Joshua, McHenry, M. Brent, Johansen, Jennifer L., and Tykodi, Scott S.

Published
2020
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6. Supplementary Figure from Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer

Author

Sweeney, Christopher J., primary, Percent, Ivor J., primary, Babu, Sunil, primary, Cultrera, Jennifer L., primary, Mehlhaff, Bryan A., primary, Goodman, Oscar B., primary, Morris, David S., primary, Schnadig, Ian D., primary, Albany, Costantine, primary, Shore, Neal D., primary, Sieber, Paul R., primary, Guba, Susan C., primary, Zhang, Wei, primary, Wacheck, Volker, primary, Donoho, Gregory P., primary, Szpurka, Anna M., primary, Callies, Sophie, primary, Lin, Boris Kin, primary, and Bendell, Johanna C., primary

Published
2023
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7. Supplementary Data from Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer

Author

Sweeney, Christopher J., primary, Percent, Ivor J., primary, Babu, Sunil, primary, Cultrera, Jennifer L., primary, Mehlhaff, Bryan A., primary, Goodman, Oscar B., primary, Morris, David S., primary, Schnadig, Ian D., primary, Albany, Costantine, primary, Shore, Neal D., primary, Sieber, Paul R., primary, Guba, Susan C., primary, Zhang, Wei, primary, Wacheck, Volker, primary, Donoho, Gregory P., primary, Szpurka, Anna M., primary, Callies, Sophie, primary, Lin, Boris Kin, primary, and Bendell, Johanna C., primary

Published
2023
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9. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials

Author

Rapoport, Bernardo L, Chasen, Martin R, Gridelli, Cesare, Urban, Laszlo, Modiano, Manuel R, Schnadig, Ian D, Poma, Allen, Arora, Sujata, Kansra, Vikram, Schwartzberg, Lee S, and Navari, Rudolph M

Published
2015
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10. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial

Author

Schwartzberg, Lee S, Modiano, Manuel R, Rapoport, Bernardo L, Chasen, Martin R, Gridelli, Cesare, Urban, Laszlo, Poma, Allen, Arora, Sujata, Navari, Rudolph M, and Schnadig, Ian D

Published
2015
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12. A randomized, phase 2 trial of docetaxel with or without PX-866, an irreversible oral phosphatidylinositol 3-kinase inhibitor, in patients with relapsed or metastatic head and neck squamous cell cancer

Author

Jimeno, Antonio, Bauman, Julie E., Weissman, Charles, Adkins, Douglas, Schnadig, Ian, Beauregard, Patrice, Bowles, Daniel W., Spira, Alexander, Levy, Benjamin, Seetharamu, Nagashree, Hausman, Diana, Walker, Luke, Rudin, Charles M., and Shirai, Keisuke

Published
2015
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15. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Powles, Thomas, primary, Tomczak, Piotr, additional, Park, Se Hoon, additional, Venugopal, Balaji, additional, Ferguson, Thomas, additional, Symeonides, Stefan N, additional, Hajek, Jaroslav, additional, Gurney, Howard, additional, Chang, Yen-Hwa, additional, Lee, Jae Lyun, additional, Sarwar, Naveed, additional, Thiery-Vuillemin, Antoine, additional, Gross-Goupil, Marine, additional, Mahave, Mauricio, additional, Haas, Naomi B, additional, Sawrycki, Piotr, additional, Burgents, Joseph E, additional, Xu, Lei, additional, Imai, Kentaro, additional, Quinn, David I, additional, Choueiri, Toni K, additional, Choueiri, Toni, additional, Ferguson, Thomas R., additional, Lin, Tzu-Ping, additional, Symeonides, Stefan N., additional, Haas, Naomi B., additional, Gurney, Howard P., additional, Chevreau, Christine, additional, Burke, John M., additional, Doshi, Gurjyot, additional, Melichar, Bohuslav, additional, Topart, Delphine, additional, Oudard, Stephane, additional, Kopyltsov, Evgeniy, additional, Hammers, Hans-Joerg, additional, Quinn, David I., additional, Alva, Ajjai, additional, Menezes, Juliana de Janoski, additional, Silva, Adriano Goncalves e, additional, Winquist, Eric W., additional, Hamzaj, Alketa, additional, Procopio, Giuseppe, additional, Karaszewska, Boguslawa, additional, Nowakowska-Zajdel, Ewa M., additional, Alekseev, Boris Y., additional, Gafanov, Rustem A., additional, Izmailov, Adel, additional, Semenov, Andrey, additional, Afanasyev, Sergey G., additional, Lipatov, Oleg N., additional, Powles, Thomas B., additional, Srinivas, Sandy, additional, McDermott, David, additional, Kochuparambil, Samith T., additional, Davis, Ian D., additional, Peltola, Katriina, additional, Sabbatini, Roberto, additional, Chung, Jinsoo, additional, Shkolnik, Michail I., additional, Matveev, Vsevolod B., additional, Gajate Borau, Pablo, additional, McCune, Steven, additional, Hutson, Thomas E., additional, Dri, Alejandro, additional, Sales, Silvio Correia, additional, Yeung, Carrie, additional, Alcala Castro, Carmen Marcela, additional, Bostrom, Peter, additional, Laguerre, Brigitte, additional, Buttigliero, Consuelo, additional, de Giorgi, Ugo, additional, Fomin, Eugeniy A., additional, Zakharia, Yousef, additional, Hwang, Clara, additional, Singer, Eric A., additional, Yorio, Jeffrey T., additional, Waterhouse, David, additional, Kowalyszyn, Ruben Dario, additional, Alfie, Margarita Sonia, additional, Yanez Ruiz, Eduardo, additional, Buchler, Tomas, additional, Kankaanranta, Krista, additional, Ferretti, Gianluigi, additional, Kimura, Go, additional, Nishimura, Kazuo, additional, Masumori, Naoya, additional, Tamada, Satoshi, additional, Kato, Haruaki, additional, Kitamura, Hiroshi, additional, Danielewicz, Iwona, additional, Wojcik-Tomaszewska, Joanna, additional, Sala Gonzalez, Nuria, additional, Chiu, Kun-Yuan, additional, Atkins, Michael B., additional, Heath, Elisabeth, additional, Rojas-Uribe, Gustavo Adolfo, additional, Gonzalez Fernandez, Manuel Enrique, additional, Feyerabend, Susan, additional, Pignata, Sandro, additional, Numakura, Kazuyuki, additional, Cybulska Stopa, Bozena, additional, Zukov, Ruslan, additional, Climent Duran, Miguel Angel, additional, Maroto Rey, Pablo Jose, additional, Montesa Pino, Alvaro, additional, Chang, Chao-Hsiang, additional, Vengalil, Salil, additional, Waddell, Tom S., additional, Cobb, Patrick W., additional, Hauke, Ralph, additional, Anderson, Daniel M., additional, Sarantopoulos, John, additional, Gourdin, Theodore, additional, Zhang, Tian, additional, Jayram, Gautam, additional, Fein, Luis Enrique, additional, Harris, Carole, additional, Beato, Patricia Medeiros Milhomem, additional, Flores, Francisco, additional, Estay, Angela, additional, Rubiano, Juan Andres, additional, Bedke, Jens, additional, Hauser, Stefan, additional, Neisius, Andreas, additional, Busch, Jonas, additional, Anai, Satoshi, additional, Tsunemori, Hiroyuki, additional, Sawka, Dariusz, additional, Sikora-Kupis, Bozena, additional, Arranz, Jose Angel, additional, Delgado, Ignacio, additional, Chen, Chung-Hsin, additional, Gunderson, Elizabeth, additional, Tykodi, Scott, additional, Koletsky, Alan, additional, Chen, Kevin, additional, Agrawal, Manish, additional, Kaen, Diego Lucas, additional, Sade, Juan Pablo, additional, Tatangelo, Marcelo Daniel, additional, Parnis, Francis, additional, Barbosa, Fernando Maciel, additional, Faucher, Genevieve, additional, Iqbal, Nayyer, additional, Marceau, Daniele, additional, Paradis, Jean-Benoit, additional, Hanna, Nawar, additional, Acevedo, Alejandro, additional, Ibanez, Carolina, additional, Villanueva, Luis, additional, Galaz, Pedro Pablo, additional, Durango, Isabel Cristina, additional, Manneh, Ray, additional, Kral, Zdenek -, additional, Holeckova, Petra, additional, Hakkarainen, Heikki, additional, Ronkainen, Hanna, additional, Abadie-Lacourtoisie, Sophie, additional, Tartas, Sophie, additional, Goebell, Peter J., additional, Grimm, Marc-Oliver, additional, Hoefner, Thomas, additional, Wirth, Manfred, additional, Panic, Andrej, additional, Schultze-Seemann, Wolfgang, additional, Yokomizo, Akira, additional, Mizuno, Ryuichi, additional, Uemura, Hirotsugu, additional, Eto, Masatoshi, additional, Tsujihata, Masao, additional, Matsukawa, Yoshihisa, additional, Murakami, Yoji, additional, Kim, Miso, additional, Hamberg, Paul, additional, Marczewska-Skrodzka, Malgorzata, additional, Szczylik, Cezary, additional, Humphreys, Alison C., additional, Jiang, Peter, additional, Kumar, Birendra, additional, Lu, Gary, additional, Desai, Arpita, additional, Karam, Jose Antonio, additional, Keogh, George, additional, Fleming, Mark, additional, Zarba, Juan Jose, additional, Leiva, Viviana E., additional, Mendez, Guillermo Ariel, additional, Harris, Samuel J., additional, Brown, Stephen J., additional, Antonio Junior, Joao Neif, additional, Costamilan, Rita de Cassia, additional, Rocha, Roberto Odebrecht, additional, Muniz, David, additional, Brust, Leandro, additional, Lalani, Aly-Khan, additional, Graham, Jeffrey, additional, Levesque, Michael, additional, Orlandi, Francisco, additional, Kotasek, Rostislav, additional, Deville, Jean L., additional, Borchiellini, Delphine, additional, Merseburger, Axel, additional, Rink, Michael, additional, Roos, Frederik, additional, McDermott, Ray, additional, Oyama, Masafumi, additional, Yamamoto, Yoshiaki, additional, Tomita, Yoshihiko, additional, Miura, Yuji, additional, Ioritani, Naomasa, additional, Westgeest, Hans, additional, Kubiatowski, Tomasz, additional, Bal, Wieslaw, additional, Girones Sarrio, Regina, additional, Rowe, Julie, additional, Prow, Debra M., additional, Senecal, Francis, additional, Hashemi-Sadraei, Neda, additional, Cole, Scott W., additional, Kendall, Stephan D., additional, Richards, Donald A., additional, Schnadig, Ian D., additional, and Gupta, Mukul, additional

Published
2022
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17. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Siefker-Radtke, Arlene O, Necchi, Andrea, Park, Se Hoon, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle F, Fleming, Mark T, Rezazadeh Kalebasty, Arash, Mellado, Begoña, Varlamov, Sergei, Joshi, Monika, Duran, Ignacio, Tagawa, Scott T, Zakharia, Yousef, Akapame, Sydney, Santiago-Walker, Ademi E, Monga, Manish, O'Hagan, Anne, Loriot, Yohann, Tagawa, Scott, Flechon, Aude, Alexeev, Boris, Varlamov, Sergey, Huddart, Robert, Burgess, Earle, Rezazadeh, Arash, Siefker-Radtke, Arlene, Vano, Yann, Gasparro, Donatello, Hamzaj, Alketa, Kopyltsov, Eugeniy, Gracia Donas, Jesus, Mellado, Begona, Parikh, Omi, Schatteman, Peter, Culine, Stephane, Houédé, Nadine, Zanetta, Sylvie, Facchini, Gaetano, Scagliotti, Giorgio, Schinzari, Giovanni, Lee, Jae Lyun, Shkolnik, Mikhail, Fleming, Mark, Joshi, Monica, O'Donnell, Peter, Stöger, Herbert, Decaestecker, Karel, Dirix, Luc, Machiels, Jean Pascal, Borchiellini, Dephine, Delva, Remy, Rolland, Frederic, Hadaschik, Boris, Retz, Margitta, Rosenbaum, Eli, Basso, Umberto, Mosca, Alessandra, Lee, Hyo Jin, Shin, Dong Bok, Cebotaru, Cristina, Moreno, Victor, Perez Gracia, Jose Luis, Pinto, Alvaro, Su, Wen-Pin, Wang, Shian-Shiang, Hainsworth, John, Schnadig, Ian, Srinivas, Sandhya, Vogelzang, Nicholas, Loidl, Wolfgang, Meran, Johannes, Gross Goupil, Marine, Joly, Florence, Imkamp, Florian, Klotz, Theodor, Krege, Susanne, May, Matthias, Schultze-Seemann, Wolfgang, Strauss, Arne, Zimmermann, Uwe, Keizman, Daniel, Peer, Avivit, Sella, Avishai, Berardi, Rossana, De Giorgi, Ugo, Sternberg, Cora Nanette, Rha, Sun Young, Bulat, Iurie, Izmailov, Adel, Matveev, Vsevolod, Vladimirov, Vladimir, Carles, Joan, Font, Albert, Saez, Maribel, Syndikus, Isabel, Tarver, Kathryn, Appleman, Leonard, Burke, John, Dawson, Nancy, Jain, Sharad, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Siefker-Radtke, Arlene O, Necchi, Andrea, Park, Se Hoon, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle F, Fleming, Mark T, Rezazadeh Kalebasty, Arash, Mellado, Begoña, Varlamov, Sergei, Joshi, Monika, Duran, Ignacio, Tagawa, Scott T, Zakharia, Yousef, Akapame, Sydney, Santiago-Walker, Ademi E, Monga, Manish, O'Hagan, Anne, Loriot, Yohann, Tagawa, Scott, Flechon, Aude, Alexeev, Boris, Varlamov, Sergey, Huddart, Robert, Burgess, Earle, Rezazadeh, Arash, Siefker-Radtke, Arlene, Vano, Yann, Gasparro, Donatello, Hamzaj, Alketa, Kopyltsov, Eugeniy, Gracia Donas, Jesus, Mellado, Begona, Parikh, Omi, Schatteman, Peter, Culine, Stephane, Houédé, Nadine, Zanetta, Sylvie, Facchini, Gaetano, Scagliotti, Giorgio, Schinzari, Giovanni, Lee, Jae Lyun, Shkolnik, Mikhail, Fleming, Mark, Joshi, Monica, O'Donnell, Peter, Stöger, Herbert, Decaestecker, Karel, Dirix, Luc, Machiels, Jean Pascal, Borchiellini, Dephine, Delva, Remy, Rolland, Frederic, Hadaschik, Boris, Retz, Margitta, Rosenbaum, Eli, Basso, Umberto, Mosca, Alessandra, Lee, Hyo Jin, Shin, Dong Bok, Cebotaru, Cristina, Moreno, Victor, Perez Gracia, Jose Luis, Pinto, Alvaro, Su, Wen-Pin, Wang, Shian-Shiang, Hainsworth, John, Schnadig, Ian, Srinivas, Sandhya, Vogelzang, Nicholas, Loidl, Wolfgang, Meran, Johannes, Gross Goupil, Marine, Joly, Florence, Imkamp, Florian, Klotz, Theodor, Krege, Susanne, May, Matthias, Schultze-Seemann, Wolfgang, Strauss, Arne, Zimmermann, Uwe, Keizman, Daniel, Peer, Avivit, Sella, Avishai, Berardi, Rossana, De Giorgi, Ugo, Sternberg, Cora Nanette, Rha, Sun Young, Bulat, Iurie, Izmailov, Adel, Matveev, Vsevolod, Vladimirov, Vladimir, Carles, Joan, Font, Albert, Saez, Maribel, Syndikus, Isabel, Tarver, Kathryn, Appleman, Leonard, Burke, John, Dawson, Nancy, and Jain, Sharad

Abstract

Background Erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, was shown to be clinically active and tolerable in patients with advanced urothelial carcinoma and prespecified FGFR alterations in the primary analysis of the BLC2001 study at median 11 months of follow-up. We aimed to assess the long-term efficacy and safety of the selected regimen of erdafitinib determined in the initial part of the study. Methods The open-label, non-comparator, phase 2, BLC2001 study was done at 126 medical centres in 14 countries across Asia, Europe, and North America. Eligible patients were aged 18 years or older with locally advanced and unresectable or metastatic urothelial carcinoma, at least one prespecified FGFR alteration, an Eastern Cooperative Oncology Group performance status of 0–2, and progressive disease after receiving at least one systemic chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy or were ineligible for cisplatin. The selected regimen determined in the initial part of the study was continuous once daily 8 mg/day oral erdafitinib in 28-day cycles, with provision for pharmacodynamically guided uptitration to 9 mg/day (8 mg/day UpT). The primary endpoint was investigator-assessed confirmed objective response rate according to Response Evaluation Criteria In Solid Tumors version 1.1. Efficacy and safety were analysed in all treated patients who received at least one dose of erdafitinib. This is the final analysis of this study. This study is registered with ClinicalTrials.gov, NCT02365597. Findings Between May 25, 2015, and Aug 9, 2018, 2328 patients were screened, of whom 212 were enrolled and 101 were treated with the selected erdafitinib 8 mg/day UpT regimen. The data cutoff date for this analysis was Aug 9, 2019. Median efficacy follow-up was 24·0 months (IQR 22·7–26·6). The investigator-assessed objective response rate for patients treated with the selected erdafitinib regimen was 40 (40%; 95% CI 30–49

Published
2022

19. Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer

Author

Sweeney, Christopher J., primary, Percent, Ivor J., additional, Babu, Sunil, additional, Cultrera, Jennifer L., additional, Mehlhaff, Bryan A., additional, Goodman, Oscar B., additional, Morris, David S., additional, Schnadig, Ian D., additional, Albany, Costantine, additional, Shore, Neal D., additional, Sieber, Paul R., additional, Guba, Susan C., additional, Zhang, Wei, additional, Wacheck, Volker, additional, Donoho, Gregory P., additional, Szpurka, Anna M., additional, Callies, Sophie, additional, Lin, Boris Kin, additional, and Bendell, Johanna C., additional

Published
2022
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20. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study

Author

Siefker-Radtke, Arlene O, primary, Necchi, Andrea, additional, Park, Se Hoon, additional, García-Donas, Jesús, additional, Huddart, Robert A, additional, Burgess, Earle F, additional, Fleming, Mark T, additional, Rezazadeh Kalebasty, Arash, additional, Mellado, Begoña, additional, Varlamov, Sergei, additional, Joshi, Monika, additional, Duran, Ignacio, additional, Tagawa, Scott T, additional, Zakharia, Yousef, additional, Akapame, Sydney, additional, Santiago-Walker, Ademi E, additional, Monga, Manish, additional, O'Hagan, Anne, additional, Loriot, Yohann, additional, Tagawa, Scott, additional, Flechon, Aude, additional, Alexeev, Boris, additional, Varlamov, Sergey, additional, Huddart, Robert, additional, Burgess, Earle, additional, Rezazadeh, Arash, additional, Siefker-Radtke, Arlene, additional, Vano, Yann, additional, Gasparro, Donatello, additional, Hamzaj, Alketa, additional, Kopyltsov, Eugeniy, additional, Gracia Donas, Jesus, additional, Mellado, Begona, additional, Parikh, Omi, additional, Schatteman, Peter, additional, Culine, Stephane, additional, Houédé, Nadine, additional, Zanetta, Sylvie, additional, Facchini, Gaetano, additional, Scagliotti, Giorgio, additional, Schinzari, Giovanni, additional, Lee, Jae Lyun, additional, Shkolnik, Mikhail, additional, Fleming, Mark, additional, Joshi, Monica, additional, O'Donnell, Peter, additional, Stöger, Herbert, additional, Decaestecker, Karel, additional, Dirix, Luc, additional, Machiels, Jean Pascal, additional, Borchiellini, Dephine, additional, Delva, Remy, additional, Rolland, Frederic, additional, Hadaschik, Boris, additional, Retz, Margitta, additional, Rosenbaum, Eli, additional, Basso, Umberto, additional, Mosca, Alessandra, additional, Lee, Hyo Jin, additional, Shin, Dong Bok, additional, Cebotaru, Cristina, additional, Moreno, Victor, additional, Perez Gracia, Jose Luis, additional, Pinto, Alvaro, additional, Su, Wen-Pin, additional, Wang, Shian-Shiang, additional, Hainsworth, John, additional, Schnadig, Ian, additional, Srinivas, Sandhya, additional, Vogelzang, Nicholas, additional, Loidl, Wolfgang, additional, Meran, Johannes, additional, Gross Goupil, Marine, additional, Joly, Florence, additional, Imkamp, Florian, additional, Klotz, Theodor, additional, Krege, Susanne, additional, May, Matthias, additional, Schultze-Seemann, Wolfgang, additional, Strauss, Arne, additional, Zimmermann, Uwe, additional, Keizman, Daniel, additional, Peer, Avivit, additional, Sella, Avishai, additional, Berardi, Rossana, additional, De Giorgi, Ugo, additional, Sternberg, Cora Nanette, additional, Rha, Sun Young, additional, Bulat, Iurie, additional, Izmailov, Adel, additional, Matveev, Vsevolod, additional, Vladimirov, Vladimir, additional, Carles, Joan, additional, Font, Albert, additional, Saez, Maribel, additional, Syndikus, Isabel, additional, Tarver, Kathryn, additional, Appleman, Leonard, additional, Burke, John, additional, Dawson, Nancy, additional, and Jain, Sharad, additional

Published
2022
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22. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Powles, Thomas, primary, Csőszi, Tibor, additional, Özgüroğlu, Mustafa, additional, Matsubara, Nobuaki, additional, Géczi, Lajos, additional, Cheng, Susanna Y-S, additional, Fradet, Yves, additional, Oudard, Stephane, additional, Vulsteke, Christof, additional, Morales Barrera, Rafael, additional, Fléchon, Aude, additional, Gunduz, Seyda, additional, Loriot, Yohann, additional, Rodriguez-Vida, Alejo, additional, Mamtani, Ronac, additional, Yu, Evan Y, additional, Nam, Kijoeng, additional, Imai, Kentaro, additional, Homet Moreno, Blanca, additional, Alva, Ajjai, additional, Cascallar, Diana Vera, additional, Varela, Mirta, additional, Lazzaro, Mauricio Fernandez, additional, Kaen, Diego Lucas, additional, Gatica, Gabriela, additional, Flores, David Hugo, additional, Falco, Agustin, additional, Molina, Matias, additional, Van Aelst, Filip, additional, Sautois, Brieuc, additional, Machiels, Jean-Pascal, additional, Schallier, Denis, additional, Brust, Leandro, additional, Rapatoni, Liane, additional, Azevedo, Sergio J, additional, Marinho, Gisele, additional, Soares, Joao Paulo Holanda, additional, Dzik, Carlos, additional, Almeida Silva, Jamile, additional, Fay, Andre Poisl, additional, Gingerich, Joel, additional, Ferrario, Cristiano, additional, Potvin, Kylea, additional, Vanhuyse, Marie, additional, Abdelsalam, Mahmoud, additional, Cheng, Susanna, additional, Caglevic, Christian, additional, Reyes, Felipe, additional, Leal, Jose Luis, additional, Francisco, Francisco, additional, Ibanez, Carolina, additional, Joly, Florence, additional, Laguerre, Brigitte, additional, Ladoire, Sylvain, additional, Flechon, Aude, additional, Topart, Delphine, additional, Huillard, Olivier, additional, Oudard, Stéphane, additional, Gross-Goupil, Marine, additional, Culine, Stephane, additional, Gravis, Gwenaelle, additional, Reichardt, Peter, additional, Retz, Margitta, additional, Herden, Jan, additional, Pfister, David, additional, Ohlman, Carsten, additional, Stoeckle, Michael, additional, Wirth, Manfred, additional, Lorch, Anja, additional, Niegisch, Guenter, additional, Goebell, Peter J, additional, Boegemann, Martin, additional, Merseburger, Axel, additional, Gakis, Georgios, additional, Bedke, Jens, additional, Neisius, Andreas, additional, Thomas, Christian, additional, Hoefner, Thomas, additional, Telekes, Andras, additional, Kosa, Judit Erzsebet, additional, Revesz, Janos, additional, Bodoky, Gyorgy, additional, Csoszi, Tibor, additional, Csejtei, Andras, additional, Geczi, Lajos, additional, Ruzsa, Agnes, additional, Kolonics, Zsuzsanna, additional, Erfan, Jozsef, additional, McDermott, Ray, additional, Bambury, Richard, additional, Sella, Avishay, additional, Frank, Stephen Jay, additional, Kejzman, Daniel, additional, Goldman, Olesya, additional, Rosenbaum, Eli, additional, Peer, Avivit, additional, Berger, Raanan, additional, Rouvinov, Keren, additional, Sarid, David, additional, Fukasawa, Satoshi, additional, Arai, Gaku, additional, Yamaguchi, Akito, additional, Yokomizo, Akira, additional, Takayama, Tatsuya, additional, Kinoshita, Hidefumi, additional, Kikuchi, Eiji, additional, Mizuno, Ryuichi, additional, Fujii, Yasuhisa, additional, Sassa, Naoto, additional, Matsukawa, Yoshihisa, additional, Fujimoto, Kiyohide, additional, Tanikawa, Toshiki, additional, Tomita, Yoshihiko, additional, Nishimura, Kazuo, additional, Tsujihata, Masao, additional, Oyama, Masafumi, additional, Masumori, Naoya, additional, Kanayama, Hiroomi, additional, Takano, Toshimi, additional, Miura, Yuji, additional, Miyazaki, Jun, additional, Joraku, Akira, additional, Kimura, Tomokazu, additional, Yamamoto, Yoshiaki, additional, Kobayashi, Kazuki, additional, De Wit, Ronald, additional, Aarts, Maureen, additional, Gerritsen, Winald, additional, Los, Maartje, additional, Beerepoot, Laurens, additional, Izmailov, Adel, additional, Gorelov, Sergey Igorevich, additional, Alekseev, Boris Yakovlevich, additional, Semenov, Andrey, additional, Kostorov, Vladimir Anatolyevich, additional, Alekseev, Sergey M, additional, Zyryanov, Alexander, additional, Oschepkov, Vasiliy Nikolaevich, additional, Shidin, Vladimir Aleksandrovich, additional, Vladimirov, Vladimir Ivanovich, additional, Gafanov, Rustem Airatovich, additional, Karlov, Petr Alexandrovich, additional, Anderson, David Brian, additional, Shepherd, Lucinda, additional, Cohen, Graham Lawrence, additional, Rapoport, Bernardo Louis, additional, Ruff, Paul, additional, Lee, Nari, additional, Bae, Woo Kyun, additional, Lee, Hyo Jin, additional, Herranz, Urbano Anido, additional, Grande, Enrique, additional, Alonso Gordoa, Teresa, additional, Guma Padro, Josep, additional, Gauna, Daniel Castellano, additional, Arranz, Jose Angel, additional, Munoz Langa, Jose, additional, Sarrio, Regina Girones, additional, Montesa Pino, Alvaro, additional, Juan Fita, Maria Jose, additional, Su, Yu-Li, additional, Lin, Yung-Chang, additional, Su, Wen-Pin, additional, Shen, Ying-Chun, additional, Chang, Yen-Hwa, additional, Huang, Yi-Hsiu, additional, Sriuranpong, Virote, additional, Chansriwong, Phichai, additional, Srimuninnimit, Vichien, additional, Danchaivijitr, Pongwut, additional, Abali, Huseyin, additional, Yavuz, Sinan, additional, Ozyilkan, Ozgur, additional, Sendur, Mehmet Ali Nahit, additional, Ekenel, Meltem, additional, Ozguroglu, Mustafa, additional, Arslan, Cagatay, additional, Ozdogan, Mustafa, additional, Birtle, Alison, additional, Powles, Thomas, additional, Huddart, Robert, additional, de Santis, Maria, additional, Zarkar, Anjali, additional, Evans, Linda, additional, Hussain, Syed, additional, DiSimone, Christopher, additional, Muina, Antonio F, additional, Schlegel, Peter, additional, Jhangiani, Haresh S, additional, Harrison, Michael, additional, Slater, Dennis E, additional, Wright, David, additional, Percent, Ivor J, additional, Lin, Jianqing, additional, Hwang, Clara, additional, Gupta, Sumati, additional, Bajaj, Madhuri, additional, Galamaga, Robert, additional, Eklund, John, additional, Wallace, James, additional, Shtivelband, Mikhail, additional, Suh, Jason Jung-Gon, additional, Burhani, Nafisa, additional, Eadens, Matthew, additional, Gunturu, Krishna, additional, Burgess, Earle, additional, Wong, John, additional, Chaudhry, Arvind, additional, Van Veldhuizen, Peter, additional, Graff, Stephanie, additional, Thomas, Christian A, additional, Schnadig, Ian D, additional, Carneiro, Benedito, additional, Hussain, Maha, additional, Morgans, Alicia, additional, Fitzharris, John T, additional, Oliff, Ira A, additional, Vuky, Jacqueline, additional, Hauke, Ralph, additional, Baron, Ari, additional, Joshi, Monika, additional, Bolemon, Britt H, additional, Jiang, Peter, additional, Mega, Anthony E, additional, Markus, Maurice, additional, Pfanzelter, Nicklas, additional, Lawler, William Eyre, additional, Cobb, Patrick Wayne, additional, Courtright, Jay G, additional, Jain, Sharad, additional, Doshi, Gurjyot, additional, Gunuganti, Vijay K, additional, Sartor, Oliver Alton, additional, Cole, Scott W, additional, Babiker, Hani, additional, Uchio, Edward M, additional, Drakaki, Alexandra, additional, Mannuel, Heather D, additional, Guancial, Elizabeth, additional, Fung, Chunkit, additional, Charles, Anthony, additional, Amato, Robert J, additional, Arriaga, Yull, additional, Bowman, Isaac, additional, Ades, Steven, additional, Dreicer, Robert, additional, Yu, Evan, additional, Quinn, David I, additional, and Fleming, Mark, additional

Published
2021
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25. Clinical decision support tools (CDST) provide education at the point-of-care to assist provider treatment choices.

Author

Ginsburg, Aimee, primary, Wilfong, Lalan S., additional, Denduluri, Neelima, additional, Howell, Josh, additional, Dickens, Andrea, additional, Casey, Kelly Leigh, additional, Hsieh, Angela, additional, Burke, John M., additional, Cowey, Charles Lance, additional, Hoverman, J. Russell, additional, Knowles, Lynne M., additional, Konduri, Kartik, additional, Larson, Tim, additional, Paulson, Andrew Scott, additional, Schnadig, Ian D., additional, Andorsky, David Jacob, additional, Neubauer, Marcus A., additional, and Patt, Debra A., additional

Published
2020
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27. Phase 1b/2 study of enzalutamide (ENZ) with LY3023414 (LY) or placebo (PL) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) after progression on abiraterone.

Author

Sweeney, Christopher, primary, Percent, Ivor John, additional, Babu, Sunil, additional, Cultrera, Jennifer, additional, Mehlhaff, Bryan Allyn, additional, Goodman, Oscar B., additional, Morris, David, additional, Schnadig, Ian D., additional, Albany, Costantine, additional, Shore, Neal D., additional, Sieber, Paul R, additional, Guba, Susan, additional, Wang, Minmin, additional, Kang, Suhyun, additional, Wacheck, Volker, additional, Donoho, Gregory P, additional, Szpurka, Anna M., additional, Callies, Sophie, additional, Lin, Boris K., additional, and Bendell, Johanna C., additional

Published
2019
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28. Real-world PROCEED registry data: Sipuleucel-T in elderly men with metastatic castration-resistant prostate cancer (mCRPC).

Author

Armstrong, Andrew J., primary, Olsson, Carl A, additional, Schnadig, Ian D., additional, Concepcion, Raoul S, additional, Vacirca, Jeffrey L., additional, Tutrone, Ronald F, additional, Dakhil, Shaker R., additional, Chang, Nancy N., additional, Tang, Hong, additional, Brown, Bruce, additional, and Vogelzang, Nicholas J., additional

Published
2019
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29. Sipuleucel-T (sip-T) overall survival (OS) and clinical outcomes by baseline (BL) prostate-specific antigen (PSA) quartiles in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): PROCEED registry.

Author

Sartor, A. Oliver, primary, Higano, Celestia S., additional, Cooperberg, Matthew R., additional, Vogelzang, Nicholas J., additional, Dakhil, Shaker R., additional, Pieczonka, Christopher Michael, additional, Vacirca, Jeff, additional, Concepcion, Raoul S, additional, Tutrone, Ronald F, additional, Nordquist, Luke T., additional, Olsson, Carl A, additional, Penson, David F., additional, Schnadig, Ian, additional, Bailen, James L., additional, Mehlhaff, Bryan, additional, Chang, Nancy N., additional, Sheikh, Nadeem Anwar, additional, Brown, Bruce, additional, and Armstrong, Andrew J., additional

Published
2018
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30. Recent developments in the clinical pharmacology of rolapitant: subanalyses in specific populations

Author

Rapoport,Bernardo, Aapro,Matti, Chasen,Martin, Jordan,Karin, Navari,Rudolph, Schnadig,Ian, Schwartzberg,Lee, Rapoport,Bernardo, Aapro,Matti, Chasen,Martin, Jordan,Karin, Navari,Rudolph, Schnadig,Ian, and Schwartzberg,Lee

Abstract

Bernardo Leon Rapoport,1 Matti Aapro,2 Martin R Chasen,3 Karin Jordan,4 Rudolph M Navari,5 Ian Schnadig,6 Lee Schwartzberg7 1The Medical Oncology Centre of Rosebank, Johannesburg, South Africa; 2Breast Center, Genolier Cancer Center, Genolier, Switzerland; 3Palliative Care, William Osler Health Services, Brampton, ON, Canada; 4Department of Medicine V, University of Heidelberg, Heidelberg, Germany; 5Division of Hematology Oncology, University of Alabama School of Medicine, Birmingham, AL, USA; 6Compass Oncology, US Oncology Research, Tualatin, OR, USA; 7West Clinic, Memphis, TN, USA Abstract: Knowledge of the involvement of the neurokinin substance P in emesis has led to the development of the neurokinin-1 receptor antagonists (NK-1 RAs) for control of chemotherapy-induced nausea and vomiting (CINV), in combination with serotonin type 3 receptor antagonists and corticosteroids. The NK-1 RA rolapitant, recently approved in oral formulation, has nanomolar affinity for the NK-1 receptor, as do the other commercially available NK-1 RAs, aprepitant and netupitant. Rolapitant is rapidly absorbed and has a long half-life in comparison to aprepitant and netupitant. All three NK-1 RAs undergo metabolism by cytochrome P450 (CYP) 3A4, necessitating caution with the concomitant use of CYP3A4 inhibitors, but in contrast to aprepitant and netupitant, rolapitant does not inhibit or induce CYP3A4. However, rolapitant is a moderate inhibitor of CYP2D6, and concomitant use with CYP2D6 substrates with narrow therapeutic indices should be avoided. Aprepitant, netupitant, and rolapitant have all demonstrated efficacy in the control of delayed CINV in patients receiving moderately and highly emetogenic chemotherapy in randomized controlled trials, including over multiple cycles of chemotherapy. We reviewed recent post hoc analyses of clinical trial data demonstrating that rolapitant is efficacious in the control of CINV in patient populations with specific tumor types, namely, breast can

Published
2017

32. APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

Author

Schnadig, Ian, primary, Agajanian, Richy, additional, Dakhil, Christopher, additional, Gabrail, Nashat, additional, Vacirca, Jeffrey, additional, Taylor, Charles, additional, Wilks, Sharon, additional, Braun, Eduardo, additional, Mosier, Michael, additional, Geller, Robert, additional, Schwartzberg, Lee, additional, and Vogelzang, Nicholas, additional

Published
2017
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34. A Randomized, Phase II Trial of Cetuximab With or Without PX-866, an Irreversible Oral Phosphatidylinositol 3-Kinase Inhibitor, in Patients With Metastatic Colorectal Carcinoma

Author

Bowles, Daniel W., primary, Kochenderfer, Mark, additional, Cohn, Allen, additional, Sideris, Lucas, additional, Nguyen, Nghia, additional, Cline-Burkhardt, Vivian, additional, Schnadig, Ian, additional, Choi, Minsig, additional, Nabell, Lisle, additional, Chaudhry, Arvind, additional, Ruxer, Robert, additional, Ucar, Antonio, additional, Hausman, Diana, additional, Walker, Luke, additional, Spira, Alexander, additional, and Jimeno, Antonio, additional

Published
2016
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37. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy

Author

Schnadig, Ian D, primary, Agajanian, Richy, additional, Dakhil, Christopher, additional, Gabrail, Nashat Y, additional, Smith, Robert E, additional, Taylor, Charles, additional, Wilks, Sharon T, additional, Schwartzberg, Lee S, additional, Cooper, William, additional, Mosier, Michael C, additional, Payne, J Yvette, additional, Klepper, Michael J, additional, and Vacirca, Jeffrey L, additional

Published
2016
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45. Phase III study of APF530 versus ondansetron with a neurokinin 1 antagonist + corticosteroid in preventing highly emetogenic chemotherapy-induced nausea and vomiting: MAGIC trial.

Author

Schnadig, Ian D., primary, Agajanian, Richy, additional, Dakhil, Shaker R., additional, Gabrail, Nashat Y., additional, Smith, Robert E., additional, Taylor, Charles W., additional, Wilks, Sharon, additional, Cooper, William, additional, Mosier, Michael, additional, Payne, Yvette, additional, Klepper, Michael, additional, and Vacirca, Jeffrey L., additional

Published
2015
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49. APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide-based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

Author

Schnadig, Ian D., Agajanian, Richy, Dakhil, Christopher, Gabrail, Nashat, Vacirca, Jeffrey, Taylor, Charles, Wilks, Sharon, Braun, Eduardo, Mosier, Michael C., Geller, Robert B., Schwartzberg, Lee, and Vogelzang, Nicholas

Subjects
ONDANSETRON, CANCER chemotherapy, NAUSEA, ANTHRACYCLINES, CYCLOPHOSPHAMIDE
Abstract

Background: APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial. Patients and methods: This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg) or ondansetron 0.15 mg/kg intravenously (IV) (≤16 mg); stratification was by planned cisplatin ≥50 mg/m2 (yes/no). Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%). The primary end point was delayed-phase (>24-120 hours) complete response (CR). Results: APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0-120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population. Conclusion: APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging. [ABSTRACT FROM AUTHOR]

Published
2017
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50. Effect of clinical NGS-based cancer genomic profiling on physician treatment decisions in advanced solid tumors.

Author

Braiteh, Fadi S., primary, Sharman, Jeff Porter, additional, Richards, Donald A., additional, Skelton, Matthew Rama, additional, DeMarco, Linda Cheryl, additional, Vukelja, Sasha, additional, Schnadig, Ian, additional, Wilks, Sharon, additional, Yasenchak, Christopher A., additional, Goldschmidt, Jerome H., additional, Resta, Regina, additional, Richey, Stephen Lane, additional, Smith, John W., additional, Asmar, Lina, additional, Wang, Yunfei, additional, Morcos, Ann, additional, Locke, Tracy, additional, Li, Yali, additional, and Palmer, Gary A., additional

Published
2014
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