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4. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): a phase 2 study

Author

Zinzani, Pier Luigi, Trněný, Marek, Ribrag, Vincent, Zilioli, Vittorio Ruggero, Walewski, Jan, Christensen, Jacob Haaber, Delwail, Vincent, Rodriguez, Guillermo, Venugopal, Parameswaran, Coleman, Morton, Dartigeas, Caroline, Patti, Caterina, Pane, Fabrizio, Jurczak, Wojciech, Taszner, Michal, Paneesha, Shankara, Zheng, Fred, DeMarini, Douglas J., Jiang, Wei, Gilmartin, Aidan, and Mehta, Amitkumar

Published
2023
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5. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies

Author

Falchook, Gerald, Rosen, Seth, LoRusso, Patricia, Watts, Justin, Gupta, Shilpa, Coombs, Catherine C, Talpaz, Moshe, Kurzrock, Razelle, Mita, Monica, Cassaday, Ryan, Harb, Wael, Peguero, Julio, Smith, David C, Piha-Paul, Sarina A, Szmulewitz, Russ, Noel, Marcus S, Yeleswaram, Swamy, Liu, Phillip, Switzky, Julie, Zhou, Gongfu, Zheng, Fred, and Mehta, Amitkumar

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Boronic Acids, Dose-Response Relationship, Drug, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, Nausea, Neoplasms, Organic Chemicals, Proteins, Pyrimidines, Tissue Distribution, Treatment Outcome, Vomiting, Young Adult, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeBromodomain and extraterminal (BET) proteins are key epigenetic transcriptional regulators, inhibition of which may suppress oncogene expression. We report results from 2 independent first-in-human phase 1/2 dose-escalation and expansion, safety and tolerability studies of BET inhibitors INCB054329 (study INCB 54329-101; NCT02431260) and INCB057643 (study INCB 57643-101; NCT02711137).Patients and methodsPatients (≥18 years) with advanced malignancies, ≥1 prior therapy, and adequate organ functions received oral INCB054329 (monotherapy) or INCB057643 (monotherapy or in combination with standard-of-care) in 21-day cycles (or 28-day cycles depending on standard-of-care combination). Primary endpoints were safety and tolerability.ResultsSixty-nine and 134 patients received INCB054329 and INCB057643, respectively. Study INCB 54329-101 has been completed; INCB 57643-101 is currently active, but not recruiting (no patients were receiving treatment as of January 8, 2019). Terminal elimination half-life was shorter for INCB054329 versus INCB057643 (mean [SD], 2.24 [2.03] vs. 11.1 [8.27] hours). INCB054329 demonstrated higher interpatient variability in oral clearance versus INCB057643 (CV%, 142% vs. 45.5%). Most common (>20%) any-grade treatment-related adverse events were similar for both drugs (INCB054329; INCB057643): nausea (35%; 30%), thrombocytopenia (33%; 32%), fatigue (29%; 30%), decreased appetite (26%; 22%). Two confirmed complete responses and 4 confirmed partial responses with INCB057643 were reported as best responses.ConclusionsINCB057643 exhibited a more favorable PK profile versus INCB054329; exposure-dependent thrombocytopenia was observed with both drugs which limited the target inhibition that could be safely maintained. Further efforts are required to identify patient populations that can benefit most, and an optimal dosing scheme to maximize therapeutic index.

Published
2020

6. Bromodomain and extra-terminal inhibitors—A consensus prioritisation after the Paediatric Strategy Forum for medicinal product development of epigenetic modifiers in children—ACCELERATE

Author

Pearson, Andrew DJ., DuBois, Steven G., Buenger, Vickie, Kieran, Mark, Stegmaier, Kimberly, Bandopadhayay, Pratiti, Bennett, Kelly, Bourdeaut, Franck, Brown, Patrick A., Chesler, Louis, Clymer, Jessica, Fox, Elizabeth, French, Christopher A., Germovsek, Eva, Giles, Francis J., Bender, Julia G., Hattersley, Maureen M., Ludwinski, Donna, Luptakova, Katarina, Maris, John, McDonough, Joe, Nikolova, Zariana, Smith, Malcolm, Tsiatis, Athanasios C., Vibhakar, Rajeev, Weiner, Susan, Yi, Joanna S., Zheng, Fred, and Vassal, Gilles

Published
2021
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7. POSTER: MPN-559 Bromodomain and Extra-terminal (BET) Inhibitor INCB057643 (LIMBER-103) in Patients With Relapsed or Refractory Myelofibrosis (R/R MF) and Other Advanced Myeloid Neoplasms: A Phase I Study

Author

Watts, Justin, primary, Hunter, Anthony, additional, Iurlo, Alessandra, additional, Xicoy, Blanca, additional, Palandri, Francesca, additional, Reeves, Brandi, additional, Vannucchi, Alessandro, additional, Bose, Prithviraj, additional, Diaz, Rosa, additional, Halpern, Anna, additional, Chen, Xuejun, additional, Burke, Lea, additional, Zhou, Feng, additional, Zheng, Fred, additional, and Vachhani, Pankit, additional

Published
2023
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8. MPN-559 Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 (LIMBER-103) in Patients With Relapsed or Refractory Myelofibrosis (R/R MF) and Other Advanced Myeloid Neoplasms: A Phase I Study

Author

Watts, Justin, primary, Hunter, Anthony, additional, Iurlo, Alessandra, additional, Xicoy, Blanca, additional, Palandri, Francesca, additional, Reeves, Brandi, additional, Vannucchi, Alessandro, additional, Bose, Prithviraj, additional, Diaz, Rosa, additional, Halpern, Anna, additional, Chen, Xuejun, additional, Burke, Lea, additional, Zhou, Feng, additional, Zheng, Fred, additional, and Vachhani, Pankit, additional

Published
2023
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9. P1055: BROMODOMAIN AND EXTRA-TERMINAL (BET) INHIBITOR INCB057643 (LIMBER-103) IN PATIENTS (PTS) WITH RELAPSED OR REFRACTORY MYELOFIBROSIS (R/R MF) AND OTHER ADVANCED MYELOID NEOPLASMS: A PHASE 1 STUDY

Author

Watts, Justin M., primary, Hunter, Anthony M., additional, Iurlo, Alessandra, additional, Xicoy, Blanca, additional, Palandri, Francesca, additional, Reeves, Brandi, additional, Vannucchi, Alessandro, additional, Bose, Prithviraj, additional, Ayala Diaz, Rosa, additional, Halpern, Anna B., additional, Chen, Xuejun, additional, Seguy, Francis, additional, Zhou, Feng, additional, Zheng, Fred, additional, and Vachhani, Pankit, additional

Published
2023
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11. Supplementary Data from Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies

Author

Falchook, Gerald, primary, Rosen, Seth, primary, LoRusso, Patricia, primary, Watts, Justin, primary, Gupta, Shilpa, primary, Coombs, Catherine C., primary, Talpaz, Moshe, primary, Kurzrock, Razelle, primary, Mita, Monica, primary, Cassaday, Ryan, primary, Harb, Wael, primary, Peguero, Julio, primary, Smith, David C., primary, Piha-Paul, Sarina A., primary, Szmulewitz, Russ, primary, Noel, Marcus S., primary, Yeleswaram, Swamy, primary, Liu, Phillip, primary, Switzky, Julie, primary, Zhou, Gongfu, primary, Zheng, Fred, primary, and Mehta, Amitkumar, primary

Published
2023
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13. Epacadostat Plus Pembrolizumab and Chemotherapy for Advanced Solid Tumors: Results from the Phase I/II ECHO-207/KEYNOTE-723 Study

Author

Powderly, John D, primary, Klempner, Samuel J, additional, Naing, Aung, additional, Bendell, Johanna, additional, Garrido-Laguna, Ignacio, additional, Catenacci, Daniel V T, additional, Taylor, Matthew H, additional, Lee, James J, additional, Zheng, Fred, additional, Zhou, Feng, additional, Gong, Xiaohua, additional, Gowda, Hema, additional, and Beatty, Gregory L, additional

Published
2022
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14. MPN-112 Bromodomain and Extra-terminal (BET) Inhibitor INCB057643 in Patients With Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study

Author

Vachhani, Pankit, Vannucchi, Alessandro M., Hunter, Anthony M., McMahon, Brandon, Tantravahi, Srinivas K., Iurlo, Alessandra, Xicoy, Blanca, Palandri, Francesca, Searle, Emma, Reeves, Brandi, Bose, Prithviraj, Ayala Diaz, Rosa, Halpern, Anna B., Chen, Xuejun, Burke, Lea, Zhou, Feng, Zheng, Fred, and Watts, Justin

Published
2024
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15. Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients With Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study

Author

Vachhani, Pankit, Vannucchi, Alessandro M., Hunter, Anthony M., McMahon, Brandon, Tantravahi, Srinivas K., Iurlo, Alessandra, Xicoy, Blanca, Palandri, Francesca, Searle, Emma, Reeves, Brandi, Bose, Prithviraj, Ayala Diaz, Rosa, Halpern, Anna B., Chen, Xuejun, Burke, Lea, Zhou, Feng, Zheng, Fred, and Watts, Justin

Published
2024
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16. Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma: Primary Analysis from a Phase 2 Study (CITADEL-204)

Author

Phillips, Tycel, primary, Avigdor, Abraham, additional, Gurion, Ronit, additional, Patti, Caterina, additional, Corradini, Paolo, additional, Tani, Monica, additional, Mehta, Amitkumar, additional, Lossos, Izidore S., additional, Zinzani, Pier Luigi Luigi, additional, Thieblemont, Catherine, additional, Jurczak, Wojciech, additional, Zheng, Fred, additional, Rappold, Erica, additional, Zhao, Wanying, additional, and Johnson, Peter, additional

Published
2021
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17. Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor: Primary Analysis from a Phase 2 Study (CITADEL-205)

Author

Mehta, Amitkumar, primary, Trněný, Marek, additional, Walewski, Jan, additional, Ribrag, Vincent, additional, Dartigeas, Caroline, additional, Christensen, Jacob Haaber, additional, Pane, Fabrizio, additional, Rodriguez, Guillermo, additional, Taszner, Michal, additional, Venugopal, Parameswaran, additional, Zilioli, Vittorio Ruggero, additional, Zheng, Fred, additional, DeMarini, Douglas J, additional, Jiang, Wei, additional, and Zinzani, Pier Luigi Luigi, additional

Published
2021
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18. Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma: Primary Analysis from a Phase 2 Study (CITADEL-203)

Author

Lynch, Ryan C., primary, Avigdor, Abraham, additional, McKinney, Matthew S, additional, Paneesha, Shankara, additional, Wahlin, Björn, additional, Hrom, John S, additional, Cunningham, David, additional, Morley, Nicholas, additional, Canales, Miguel, additional, Bastos-Oreiro, Mariana, additional, Belada, David, additional, Devizzi, Liliana, additional, Zheng, Fred, additional, DeMarini, Douglas J, additional, Jiang, Wei, additional, and Trněný, Marek, additional

Published
2021
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20. Bromodomain and Extra-Terminal Inhibitor INCB057643 (LIMBER-103) in Patients with Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study

Author

Watts, Justin M., Vannucchi, Alessandro M., Hunter, Anthony M., McMahon, Brandon, Tantravahi, Srinivas K., Iurlo, Alessandra, Xicoy, Blanca, Palandri, Francesca, Searle, Emma, Reeves, Brandi N., Bose, Prithviraj, Ayala, Rosa, Halpern, Anna B., Chen, Xuejun, Burke, Lea M, Zhou, Feng, Zheng, Fred, and Vachhani, Pankit

Published
2023
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21. Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor (CITADEL-205)

Author

Mehta, Amitkumar, primary, Trněný, Marek, additional, Walewski, Jan, additional, Ribrag, Vincent, additional, Dartigeas, Caroline, additional, Christensen, Jacob Haaber, additional, Pane, Fabrizio, additional, Rodríguez, Guillermo, additional, Taszner, Michal, additional, Venugopal, Parameswaran, additional, Zilioli, Vittorio Ruggero, additional, Zheng, Fred, additional, DeMarini, Douglas J, additional, Jiang, Wei, additional, and Zinzani, Pier Luigi, additional

Published
2020
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22. Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Author

Phillips, Tycel J., primary, Corradini, Paolo, additional, Gurion, Ronit, additional, Patti, Caterina, additional, Tani, Monica, additional, Avigdor, Abraham, additional, Jurczak, Wojciech, additional, Mehta, Amitkumar, additional, Zinzani, Pier Luigi, additional, Lossos, Izidore S., additional, Thieblemont, Catherine, additional, Zheng, Fred, additional, Rappold, Erica, additional, Zhao, Wanying, additional, and Johnson, Peter, additional

Published
2020
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23. Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

Author

Lynch, Ryan C., primary, Paneesha, Shankara, additional, Avigdor, Abraham, additional, McKinney, Matthew S, additional, Wahlin, Björn E, additional, Hrom, John S, additional, Belada, David, additional, Canales, Miguel, additional, Cunningham, David, additional, Devizzi, Liliana, additional, Morley, Nicholas, additional, Zheng, Fred, additional, DeMarini, Douglas J, additional, Jiang, Wei, additional, and Trněný, Marek, additional

Published
2020
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24. Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Previously Treated with Ibrutinib (CITADEL-205)

Author

Zinzani, Pier Luigi, primary, Delwail, Vincent, additional, Paneesha, Shankara, additional, Rule, Simon, additional, Martin Garcia-Sancho, Alejandro, additional, Marin-Niebla, Ana, additional, Salles, Gilles, additional, Sancho, Juan-Manuel, additional, Vergote, Vibeke, additional, Zilioli, Vittorio Ruggero, additional, Zheng, Fred, additional, DeMarini, Douglas J, additional, Jiang, Wei, additional, and Mehta, Amitkumar, additional

Published
2020
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26. Abstract A093: Phase 1/2 study of INCB054329, a bromodomain and extraterminal (BET) protein inhibitor, in patients (pts) with advanced malignancies

Author

Falchook, Gerald, primary, Talpaz, Moshe, additional, Mita, Monica, additional, Szmulewitz, Russ, additional, Piha-Paul, Sarina, additional, Harb, Wael, additional, Morgensztern, Daniel, additional, Kaplan, Jason, additional, Munster, Pamela, additional, Cornell, Robert F., additional, Zheng, Fred, additional, Yeleswaram, Swamy, additional, Zhou, Gongfu, additional, and Cassaday, Ryan, additional

Published
2018
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29. Bromodomain and extra-terminal (BET) inhibitor INCB057643 (LIMBER-103) in patients (pts) with relapsed or refractory myelofibrosis (R/R MF) and other advanced myeloid neoplasms: A phase 1 study.

Author

Watts, Justin M., Hunter, Anthony, Iurlo, Alessandra, Xicoy, Blanca, Palandri, Francesca, Reeves, Brandi, Vannucchi, Alessandro M., Bose, Prithviraj, Diaz, Rosa Ayala, Halpern, Anna B., Chen, Xuejun, Seguy, Francis, Zhou, Feng, Zheng, Fred, and Vachhani, Pankit

Published
2023
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30. A Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Flinn, Ian, primary, Bartlett, Nancy L., additional, Blum, Kristie A., additional, Ardeshna, Kirit M, additional, LaCasce, Ann, additional, Flowers, Christopher R., additional, Shustov, Andrei R., additional, Thress, Kenneth, additional, Zheng, Fred, additional, Skolnik, Jeffery, additional, and Friedberg, Jonathan W., additional

Published
2014
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