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29 results on '"Siguero, Mariano"'

1. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study

Author

Kristeleit, Rebecca, Leary, Alexandra, Delord, Jean Pierre, Moreno, Victor, Oaknin, Ana, Castellano, Daniel, Shappiro, Geoffrey I., Fernández, Cristian, Kahatt, Carmen, Alfaro, Vicente, Siguero, Mariano, Rueda, Daniel, Zeaiter, Ali, Awada, Ahmad, Santaballa, Ana, Zaman, Khalil, Sehouli, Jalid, and Subbiah, Vivek

Published
2023
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4. Safety analysis of lurbinectedin versus topotecan in elderly patients.

Author

Subbiah, Vivek, primary, Lorusso, Domenica, additional, Trigo Perez, Jose Manuel Manuel, additional, Leary, Alexandra, additional, Moreno, Victor, additional, Kristeleit, Rebecca, additional, Vergote, Ignace, additional, Lopez-Vilariño, Jose Antonio, additional, Fernandez, Cristian Marcelo, additional, Siguero, Mariano, additional, Kahatt, Carmen Maria, additional, Zeaiter, Ali Hassan, additional, Boni, Valentina, additional, Navarro, Alejandro, additional, Gutierrez Calderon, Vanesa, additional, Pardo, Beatriz, additional, Berton, Dominique, additional, and Scambia, Giovanni, additional

Published
2023
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6. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study

Author

Longo-Muñoz, Federico, primary, Castellano, Daniel, additional, Alexandre, Jerome, additional, Chawla, Sant P., additional, Fernández, Cristian, additional, Kahatt, Carmen, additional, Alfaro, Vicente, additional, Siguero, Mariano, additional, Zeaiter, Ali, additional, Moreno, Victor, additional, Sanz-García, Enrique, additional, Awada, Ahmad, additional, Santaballa, Ana, additional, and Subbiah, Vivek, additional

Published
2022
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7. Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study.

Author

Boni, Valentina, primary, Pistilli, Barbara, additional, Brana, Irene, additional, Shapiro, Geoffrey, additional, Trigo Perez, Jose Manuel Manuel, additional, Moreno, Victor, additional, Castellano, Daniel E., additional, Fernandez, Cristian Marcelo, additional, Kahatt, Carmen Maria, additional, Alfaro, Vicente, additional, Siguero, Mariano, additional, Zeaiter, Ali Hassan, additional, Longo, Federico, additional, Zaman, Khalil, additional, Antón Torres, Antonio, additional, Paredes Lario, Alfredo, additional, Huidobro Vence, Gerardo, additional, and Subbiah, Vivek, additional

Published
2022
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8. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study

Author

Subbiah, Vivek, Braña, Irene, Longhi, Alessandra, Boni, Valentina, Delord, Jean Pierre, Awada, Ahmad, Boudou-Rouquette, Pascaline, Sarantopoulos, John, Shapiro, Geoffrey G.I., Elias, Anthony A.D., Ratan, Ravin, Fernández, Cristian, Kahatt, Carmen, Cullell-Young, Martin, Siguero, Mariano, Zeaiter, Ali, Chawla, Sant, Subbiah, Vivek, Braña, Irene, Longhi, Alessandra, Boni, Valentina, Delord, Jean Pierre, Awada, Ahmad, Boudou-Rouquette, Pascaline, Sarantopoulos, John, Shapiro, Geoffrey G.I., Elias, Anthony A.D., Ratan, Ravin, Fernández, Cristian, Kahatt, Carmen, Cullell-Young, Martin, Siguero, Mariano, Zeaiter, Ali, and Chawla, Sant

Abstract

Purpose: Lurbinectedin suppresses the oncogenic transcription factor EWS-FLI1 through relocalization to the nucleolus, and delays tumor growth in mice bearing Ewing sarcoma xenografts. On the basis of this rationale, lurbinectedin was evaluated in patients with relapsed Ewing sarcoma. Patients and Methods: This open-label, single-arm, Basket phase II trial included a cohort of 28 treated adult patients with confirmed Ewing sarcoma, measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1, Eastern Cooperative Oncology Group performance status ≤2, adequate organ function, no central nervous system metastasis, and pretreated with ≤2 chemotherapy lines for metastatic/recurrent disease. Patients received lurbinectedin 3.2mg/m2 as a 1-hour infusion every 3 weeks. Primary endpoint was overall response rate (ORR) as per RECIST v.1.1. Secondary endpoints included time-to-event parameters and safety profile. Results: ORR was 14.3% [95% confidence interval (CI), 4.0%-32.7%], with median duration of response of 4.2 months (95% CI, 2.9-5.5 months). Median progression-free survival was 2.7 months (95% CI, 1.4-4.3 months), clinical benefit rate was 39.3%, and disease control rate was 57.1%. With 39% censoring, median overall survival was 12.0 months (95% CI, 8.5- 18.5 months). Most common grade 3/4 adverse events were neutropenia (57%), anemia, thrombocytopenia, and treatmentrelated febrile neutropenia (14% each). No deaths or discontinuations were due to toxicity. Conclusions: Lurbinectedin was active in the treatment of relapsed Ewing sarcoma and had a manageable safety profile. Lurbinectedin could represent a valuable addition to therapies for Ewing sarcoma, and is currently being evaluated in combination with irinotecan in advanced Ewing sarcoma in a phase Ib/II trial., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2022

9. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study

Author

Subbiah, Vivek, primary, Braña, Irene, additional, Longhi, Alessandra, additional, Boni, Valentina, additional, Delord, Jean-Pierre, additional, Awada, Ahmad, additional, Boudou-Rouquette, Pascaline, additional, Sarantopoulos, John, additional, Shapiro, Geoffrey I., additional, Elias, Anthony, additional, Ratan, Ravin, additional, Fernandez, Cristian, additional, Kahatt, Carmen, additional, Cullell-Young, Martin, additional, Siguero, Mariano, additional, Zeaiter, Ali, additional, and Chawla, Sant P., additional

Published
2022
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14. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment

Author

Subbiah, Vivek, Paz Ares, Luis, Besse, Benjamin, Moreno, Victor, Peters, Solange, Sala, María Angeles, López-Vilariño, José Antonio, Fernández, Cristian, Kahatt, Carmen, Alfaro, Vicente, Siguero, Mariano, Zeaiter, Ali, Zaman, Khalil, López, Rafael, Ponce, Santiago, Boni, Valentina, Arrondeau, Jennifer, Delord, Jean Pierre, Martínez, Maite, Wannesson, Luciano, Anton, Antonio, Valdivia, Javier, Awada, Ahmad, Kristeleit, Rebecca, Olmedo, Maria Eugenia, Rubio, María Jesús, Sarantopoulos, John, Chawla, Sant, Mosquera-Martinez, Joaquín, D’ Arcangelo, Manolo, Santoro, Armando, Villalobos, Victor Manuel, Sands, Jacob, Trigo, José, Subbiah, Vivek, Paz Ares, Luis, Besse, Benjamin, Moreno, Victor, Peters, Solange, Sala, María Angeles, López-Vilariño, José Antonio, Fernández, Cristian, Kahatt, Carmen, Alfaro, Vicente, Siguero, Mariano, Zeaiter, Ali, Zaman, Khalil, López, Rafael, Ponce, Santiago, Boni, Valentina, Arrondeau, Jennifer, Delord, Jean Pierre, Martínez, Maite, Wannesson, Luciano, Anton, Antonio, Valdivia, Javier, Awada, Ahmad, Kristeleit, Rebecca, Olmedo, Maria Eugenia, Rubio, María Jesús, Sarantopoulos, John, Chawla, Sant, Mosquera-Martinez, Joaquín, D’ Arcangelo, Manolo, Santoro, Armando, Villalobos, Victor Manuel, Sands, Jacob, and Trigo, José

Abstract

Introduction: The National Comprehensive Cancer Network guidelines recommend re-challenge with the first-line treatment for relapsed small cell lung cancer (SCLC) with chemotherapy-free interval (CTFI)≥180 days. A phase II study (NCT02454972) showed remarkable antitumor activity in SCLC patients treated with lurbinectedin 3.2 mg/m2 1 -h intravenous infusion every 3 weeks as second-line therapy. We report results for the pre-planned subset of patients with CTFI ≥ 180 days. Material and Methods: Twenty patients aged ≥18 years with pathologically proven SCLC diagnosis, pretreated with only one prior platinum-containing line, no CNS metastases, and with CTFI ≥ 180 days were evaluated. The primary efficacy endpoint was the overall response rate (ORR) assessed by the Investigators according to RECIST v1.1. Results: ORR was 60.0 % (95 %CI, 36.1−86.9), with a median duration of response of 5.5 months (95 %CI, 2.9−11.2) and disease control rate of 95.0 % (95 %CI, 75.1−99.9). Median progression-free survival was 4.6 months (95 %CI, 2.6−7.3). With a censoring of 55.0 %, the median overall survival was 16.2 months (95 %CI, 9.6-upper level not reached). Of note, 60.9 % and 27.1 % of patients were alive at 1 and 2 years, respectively. The most common grade 3/4 adverse events and laboratory abnormalities were hematological disorders (neutropenia, 55.0 %; anemia; 10.0 % thrombocytopenia, 10.0 %), fatigue (10.0 %) and increased liver function tests (GGT, 10 %; ALT and AP, 5.0 % each). No febrile neutropenia was reported. Conclusion: Lurbinectedin is an effective treatment for platinum-sensitive relapsed SCLC, especially in patients with CTFI ≥ 180 days, with acceptable safety and tolerability. These encouraging results suggest that lurbinectedin can be another valuable therapeutic option rather than platinum re-challenge., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2020

15. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment

Author

Subbiah, Vivek, primary, Paz-Ares, Luis, additional, Besse, Benjamin, additional, Moreno, Victor, additional, Peters, Solange, additional, Sala, María Angeles, additional, López-Vilariño, José Antonio, additional, Fernández, Cristian, additional, Kahatt, Carmen, additional, Alfaro, Vicente, additional, Siguero, Mariano, additional, Zeaiter, Ali, additional, Zaman, Khalil, additional, López, Rafael, additional, Ponce, Santiago, additional, Boni, Valentina, additional, Arrondeau, Jennifer, additional, Delord, Jean-Pierre, additional, Martínez, Maite, additional, Wannesson, Luciano, additional, Antón, Antonio, additional, Valdivia, Javier, additional, Awada, Ahmad, additional, Kristeleit, Rebecca, additional, Olmedo, Maria Eugenia, additional, Rubio, María Jesús, additional, Sarantopoulos, John, additional, Chawla, Sant P., additional, Mosquera-Martinez, Joaquín, additional, D’ Arcangelo, Manolo, additional, Santoro, Armando, additional, Villalobos, Victor M., additional, Sands, Jacob, additional, and Trigo, José, additional

Published
2020
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16. Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors: Updated results from a phase Ib-II trial.

Author

Ponce Aix, Santiago, primary, Cote, Gregory Michael, additional, Falcon Gonzalez, Alejandro, additional, Sepulveda, Juan Manuel, additional, Jimenez Aguilar, Elizabeth, additional, Sanchez-Simon, Inmaculada, additional, Flor, Maria José, additional, Nuñez, Rafael, additional, Gonzalez, Eva Maria, additional, Insa, Monica, additional, Siguero, Mariano, additional, Cullell-Young, Martin, additional, Kahatt, Carmen Maria, additional, Zeaiter, Ali Hassan, additional, and Paz-Ares, Luis G., additional

Published
2020
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17. Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial.

Author

Paz-Ares, Luis G., primary, Trigo Perez, Jose Manuel, additional, Besse, Benjamin, additional, Moreno, Victor, additional, Lopez, Rafael, additional, Sala, Maria Angeles, additional, Ponce Aix, Santiago, additional, Fernandez, Cristian Marcelo, additional, Siguero, Mariano, additional, Kahatt, Carmen Maria, additional, Zeaiter, Ali Hassan, additional, Zaman, Khalil, additional, Boni, Valentina, additional, Arrondeau, Jennifer, additional, Martinez Aguillo, Maite, additional, Delord, Jean-Pierre, additional, Awada, Ahmad, additional, Kristeleit, Rebecca Sophie, additional, Olmedo Garcia, Maria Eugenia, additional, and Subbiah, Vivek, additional

Published
2019
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18. Safety and tolerability of lurbinectedin (PM01183) in patients with acute myeloid leukemia and myelodysplastic syndrome

Author

Benton, Christopher B., primary, Chien, Kelly S., additional, Tefferi, Ayalew, additional, Rodriguez, Jose, additional, Ravandi, Farhad, additional, Daver, Naval, additional, Jabbour, Elias, additional, Jain, Nitin, additional, Alvarado, Yesid, additional, Kwari, Monica, additional, Pierce, Sherry, additional, Maiti, Abhishek, additional, Hornbaker, Marisa, additional, Santos, Margarida A., additional, Martinez, Sara, additional, Siguero, Mariano, additional, Zblewski, Darci, additional, Al‐Kali, Aref, additional, Hogan, William J., additional, Kantarjian, Hagop, additional, Pardanani, Animesh, additional, and Garcia‐Manero, Guillermo, additional

Published
2018
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20. Safety and Tolerability of Lurbinectedin (PM01183) in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome

Author

Chien, Kelly S., primary, Benton, Christopher B., additional, Tefferi, Ayalew, additional, Rodríguez, José, additional, Ravandi, Farhad, additional, Daver, Naval G., additional, Jabbour, Elias J., additional, Jain, Nitin, additional, Alvarado, Yesid, additional, Kwari, Monica, additional, Pierce, Sherry A., additional, Maiti, Abhishek, additional, Hornbaker, Marisa J, additional, Almeida Santos, Margarida, additional, Martinez, Sara, additional, Siguero, Mariano, additional, Zblewski, Darci, additional, Al-Kali, Aref, additional, Hogan, William J., additional, Kantarjian, Hagop M., additional, Pardanani, Animesh, additional, and Garcia-Manero, Guillermo, additional

Published
2018
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21. Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma: Final results from a phase 2 study.

Author

Subbiah, Vivek, primary, Sankhala, Kamalesh Kumar, additional, Ratan, Ravin, additional, Sanz Garcia, Enrique, additional, Boni, Valentina, additional, Gil, Thierry, additional, Villalobos, Victor Manuel, additional, Chawla, Sant P, additional, Lardelli, Pilar, additional, Siguero, Mariano, additional, Kahatt, Carmen Maria, additional, Soto-Matos, Arturo, additional, and Ferrari, Stefano, additional

Published
2018
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22. Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study.

Author

Trigo Perez, Jose Manuel, primary, Leary, Alexandra, additional, Besse, Benjamin, additional, Castellano, Daniel E., additional, Ponce Aix, Santiago, additional, ARRONDEAU, Jennifer, additional, Moreno, Victor, additional, Doger, Bernard, additional, Lopez, Rafael, additional, Awada, Ahmad, additional, Jungels, Christiane, additional, Forster, Martin David, additional, Boni, Valentina, additional, Lardelli, Pilar, additional, Siguero, Mariano, additional, Kahatt, Carmen Maria, additional, Soto-Matos, Arturo, additional, and Kristeleit, Rebecca Sophie, additional

Published
2018
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23. Anti-tumor activity of PM1183 (lurbinectedin) in combination with capecitabine in metastatic breast cancer patients: Results from a phase I trial.

Author

Awada, Ahmad, primary, Aftimos, Philippe Georges, additional, Calvo, Emiliano, additional, Boni, Valentina, additional, Moreno, Victor, additional, Doger, Bernard, additional, Luepke, Xarles Erik, additional, Zaragoza, Katrin, additional, Siguero, Mariano, additional, Kahatt, Carmen Maria, additional, Soto-Matos, Arturo, additional, Sauri, Tamara, additional, and Tabernero, Josep, additional

Published
2018
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24. Phase I study of lurbinectedin (PM11083) in patients with advanced AML and MDS.

Author

Benton, Christopher Brent, primary, Rodriguez Diaz -Pavon, Jose, additional, Maiti, Abhishek, additional, Daver, Naval Guastad, additional, Ravandi, Farhad, additional, Jain, Nitin, additional, Alvarado, Yesid, additional, Jabbour, Elias, additional, Pierce, Sherry, additional, Kwari, Monica, additional, Santos, Margarida A, additional, Martinez, Sara, additional, Siguero, Mariano, additional, Tefferi, Ayalew, additional, Cortes, Jorge E., additional, Kantarjian, Hagop M., additional, Pardanani, Animesh Dev, additional, and Garcia-Manero, Guillermo, additional

Published
2017
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25. Safety and tolerability of lurbinectedin (PM01183) in patients with acute myeloid leukemia and myelodysplastic syndrome.

Author

Benton, Christopher B., Chien, Kelly S., Tefferi, Ayalew, Rodriguez, Jose, Ravandi, Farhad, Daver, Naval, Jabbour, Elias, Jain, Nitin, Alvarado, Yesid, Kwari, Monica, Pierce, Sherry, Maiti, Abhishek, Hornbaker, Marisa, Santos, Margarida A., Martinez, Sara, Siguero, Mariano, Zblewski, Darci, Al‐Kali, Aref, Hogan, William J., and Kantarjian, Hagop

Subjects
ACUTE myeloid leukemia diagnosis, ANTINEOPLASTIC agents, BONE marrow, CHROMOSOME abnormalities, CLINICAL trials, MYELODYSPLASTIC syndromes, PYRIDINE, RESEARCH funding, ACUTE myeloid leukemia, TREATMENT effectiveness, DIAGNOSIS, THERAPEUTICS
Abstract

Trabectedin is an FDA-approved DNA minor groove binder that has activity against translocation-associated sarcomas. Lurbinectedin is a next-generation minor groove binder with preclinical activity against myeloid leukemia cells. A dose-finding phase 1 clinical trial was performed in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with further assessment of safety and tolerability. Forty-two patients with relapsed/refractory AML/MDS received lurbinectedin administered as a 1-hour intravenous infusion in a 3 + 3 study design. Two dosing schedules were used: 3.5, 5, 7, or 6 mg on days 1 and 8 or 2, 3, 1, or 1.5 mg for 3 consecutive days on days 1 to 3. Three patients experienced dose-limiting toxicities of rhabdomyolysis (grade 4), hyperbilirubinemia (grade 3), and oral herpes (grade 3) with the day 1 and 8 schedule. Otherwise, adverse events mainly consisted of gastrointestinal manifestations (n = 11), febrile neutropenia/infections (n = 4), pulmonary toxicity (n = 2), and renal failure (n = 2). The most common laboratory abnormalities observed were an increase in creatinine (93%) and anemia, neutropenia, and thrombocytopenia (100%). Overall, 33 of 42 patients (79%) had reduction in blasts in peripheral blood or bone marrow. One patient achieved a partial response and 2 patients a morphologic leukemia-free state. Most (n = 30, 71%) were discontinued due to progressive disease. Early deaths occurred from disease-related causes that were not attributable to lurbinectedin. Four patients with a chromosome 11q21-23 abnormality had significantly greater bone marrow blast reduction than those without such abnormality, with decrease of 31 ± 14% (n = 4) vs 8 ± 8% (n = 16), respectively (P = .04). Overall, lurbinectedin was safe and tolerated using the schedules and dose levels tested. While no sustained remissions were observed, single-agent lurbinectedin was transiently leukemia suppressive for some patients. [ABSTRACT FROM AUTHOR]

Published
2019
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26. Phase I clinical and pharmacokinetic study of PM01183 (a tetrahydroisoquinoline, Lurbinectedin) in combination with gemcitabine in patients with advanced solid tumors

Author

Paz-Ares, Luis, primary, Forster, Martin, additional, Boni, Valentina, additional, Szyldergemajn, Sergio, additional, Corral, Jesús, additional, Turnbull, Samantha, additional, Cubillo, Antonio, additional, Teruel, Carlos Fernandez, additional, Calderero, Iker López, additional, Siguero, Mariano, additional, Bohan, Patrick, additional, and Calvo, Emiliano, additional

Published
2016
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27. First-In-Human Phase I Study of Lurbinectedin (PM01183) in Patients with Advanced Solid Tumors

Author

Elez, María Elena, primary, Tabernero, Josep, additional, Geary, David, additional, Macarulla, Teresa, additional, Kang, S. Peter, additional, Kahatt, Carmen, additional, Pita, Arturo Soto-Matos, additional, Teruel, Carlos Fernandez, additional, Siguero, Mariano, additional, Cullell-Young, Martin, additional, Szyldergemajn, Sergio, additional, and Ratain, Mark J., additional

Published
2014
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29. Phase I study of PM00104 (Zalypsis®) administered as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors

Author

Massard, Christophe, primary, Margetts, Jane, additional, Amellal, Nadia, additional, Drew, Yvette, additional, Bahleda, Ratislav, additional, Stevens, Peter, additional, Armand, Jean Pierre, additional, Calvert, Hilary, additional, Soria, Jean Charles, additional, Coronado, Cinthya, additional, Kahatt, Carmen, additional, Alfaro, Vicente, additional, Siguero, Mariano, additional, Fernández-Teruel, Carlos, additional, and Plummer, Ruth, additional

Published
2012
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