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1. Activity of venetoclax in patients with relapsed or refractory chronic lymphocytic leukaemia: analysis of the VENICE-1 multicentre, open-label, single-arm, phase 3b trial

Author

Kater, Arnon P, Arslan, Önder, Demirkan, Fatih, Herishanu, Yair, Ferhanoglu, Burhan, Diaz, Marcos Gonzalez, Leber, Brian, Montillo, Marco, Panayiotidis, Panayiotis, Rossi, Davide, Skarbnik, Alan, Tempescul, Adrian, Turgut, Mehmet, Mellink, Clemens H, van der Kevie-Kersemaekers, Anne-Marie F, Lanham, Stuart, Sale, Ben, Del Rio, Luis, Popovic, Relja, Chyla, Brenda J, Busman, Todd, Komlosi, Viktor, Wang, Xifeng, Sail, Kavita, Pena, German E, Vizkelety, Tamas, and Forconi, Francesco

Published
2024
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2. Data from Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia

Author

Konopleva, Marina, primary, Pollyea, Daniel A., primary, Potluri, Jalaja, primary, Chyla, Brenda, primary, Hogdal, Leah, primary, Busman, Todd, primary, McKeegan, Evelyn, primary, Salem, Ahmed Hamed, primary, Zhu, Ming, primary, Ricker, Justin L., primary, Blum, William, primary, DiNardo, Courtney D., primary, Kadia, Tapan, primary, Dunbar, Martin, primary, Kirby, Rachel, primary, Falotico, Nancy, primary, Leverson, Joel, primary, Humerickhouse, Rod, primary, Mabry, Mack, primary, Stone, Richard, primary, Kantarjian, Hagop, primary, and Letai, Anthony, primary

Published
2023
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3. Supplementary Figures S1 - S3, Table S1 from Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia

Author

Konopleva, Marina, primary, Pollyea, Daniel A., primary, Potluri, Jalaja, primary, Chyla, Brenda, primary, Hogdal, Leah, primary, Busman, Todd, primary, McKeegan, Evelyn, primary, Salem, Ahmed Hamed, primary, Zhu, Ming, primary, Ricker, Justin L., primary, Blum, William, primary, DiNardo, Courtney D., primary, Kadia, Tapan, primary, Dunbar, Martin, primary, Kirby, Rachel, primary, Falotico, Nancy, primary, Leverson, Joel, primary, Humerickhouse, Rod, primary, Mabry, Mack, primary, Stone, Richard, primary, Kantarjian, Hagop, primary, and Letai, Anthony, primary

Published
2023
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4. Supplementary Data from Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., primary, Hallek, Michael, primary, Wierda, William, primary, Roberts, Andrew W., primary, Stilgenbauer, Stephan, primary, Jones, Jeffrey A., primary, Gerecitano, John F., primary, Kim, Su Young, primary, Potluri, Jalaja, primary, Busman, Todd, primary, Best, Andrea, primary, Verdugo, Maria E., primary, Cerri, Elisa, primary, Desai, Monali, primary, Hillmen, Peter, primary, and Seymour, John F., primary

Published
2023
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9. Navitoclax, a targeted high-affinity inhibitor of BCL-2, in lymphoid malignancies: a phase 1 dose-escalation study of safety, pharmacokinetics, pharmacodynamics, and antitumour activity

Author

Wilson, Wyndham H, O'Connor, Owen A, Czuczman, Myron S, LaCasce, Ann S, Gerecitano, John F, Leonard, John P, Tulpule, Anil, Dunleavy, Kieron, Xiong, Hao, Chiu, Yi-Lin, Cui, Yue, Busman, Todd, Elmore, Steven W, Rosenberg, Saul H, Krivoshik, Andrew P, Enschede, Sari H, and Humerickhouse, Rod A

Published
2010
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11. A Phase I study of the safety, pharmacokinetics and efficacy of navitoclax plus docetaxel in patients with advanced solid tumors

Author

Puglisi, Martina, primary, Molife, L Rhoda, additional, de Jonge, Maja JA, additional, Khan, Khurum H, additional, Doorn, Leni van, additional, Forster, Martin D, additional, Blanco, Montserrat, additional, Gutierrez, Martin, additional, Franklin, Catherine, additional, Busman, Todd, additional, Yang, Jianning, additional, and Eskens, Ferry ALM, additional

Published
2021
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16. Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., Hallek, Michael, Wierda, William, Roberts, Andrew W., Stilgenbauer, Stephan, Jones, Jeffrey A., Gerecitano, John F., Kim, Su Young, Potluri, Jalaja, Busman, Todd, Best, Andrea, Verdugo, Maria E., Cerri, Elisa, Desai, Monali, Hillmen, Peter, Seymour, John F., Davids, Matthew S., Hallek, Michael, Wierda, William, Roberts, Andrew W., Stilgenbauer, Stephan, Jones, Jeffrey A., Gerecitano, John F., Kim, Su Young, Potluri, Jalaja, Busman, Todd, Best, Andrea, Verdugo, Maria E., Cerri, Elisa, Desai, Monali, Hillmen, Peter, and Seymour, John F.

Abstract

Purpose: The oral BCL-2 inhibitor venetoclax is an effective therapy for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including disease with high-risk genomic features such as chromosome 17p deletion [del (17p)] or progressive disease following B-cell receptor pathway inhibitors. Patients and Methods: We conducted a comprehensive analysis of the safety of 400 mg daily venetoclax monotherapy in 350 patients with CLL using an integrated dataset from three phase I/II studies. Results: Median age was 66 years and 60% had del(17p). Patients had received a median of three prior therapies (range: 0-15); 42% previously received ibrutinib or idelalisib. Median duration of exposure to venetoclax was 16 months (0-56). In the pooled analysis, the most common adverse events (AE) of any grade were diarrhea (41%), neutropenia (40%), nausea (39%), anemia (31%), fatigue (28%), and upper respiratory tract infection (25%). The most common grade 3/4 AEs were neutropenia (37%), anemia (17%), and thrombocytopenia (14%). With the current 5-week ramp-up dosing, the incidence of laboratory TLS was 1.4% (2/166), none had clinical sequelae, and all of these patients were able to ramp-up to a daily dose of 400 mg. Grade 3/4 neutropenia was manageable with growth factor support and dose adjustments; the incidence of serious infections in these patients was 15%. Ten percent of patients discontinued venetoclax due to AEs and 8% died while on study, with the majority of deaths in the setting of disease progression. Conclusions: Venetoclax as a long-term continuous therapy is generally well tolerated in patients with R/R CLL when initiated with the current treatment algorithm. (C) 2018 AACR.

Published
2018

18. Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., primary, Hallek, Michael, additional, Wierda, William, additional, Roberts, Andrew W., additional, Stilgenbauer, Stephan, additional, Jones, Jeffrey A., additional, Gerecitano, John F., additional, Kim, Su Young, additional, Potluri, Jalaja, additional, Busman, Todd, additional, Best, Andrea, additional, Verdugo, Maria E., additional, Cerri, Elisa, additional, Desai, Monali, additional, Hillmen, Peter, additional, and Seymour, John F., additional

Published
2018
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19. Safety Profile of Venetoclax Monotherapy in Patients with Chronic Lymphocytic Leukemia

Author

Seymour, John F, primary, Davids, Matthew S., additional, Roberts, Andrew W., additional, Hallek, Michael, additional, Wierda, William G., additional, Hillmen, Peter, additional, Gerecitano, John F., additional, Cerri, Elisa, additional, Potluri, Jalaja, additional, Kim, Su Young, additional, Busman, Todd, additional, Verdugo, Maria, additional, Humerickhouse, Rod A., additional, Best, Andrea, additional, Desai, Monali, additional, and Stilgenbauer, Stephan, additional

Published
2016
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20. Safety Profile of Venetoclax Monotherapy in Patients with Chronic Lymphocytic Leukemia

Author

Seymour, John F., Davids, Matthew S., Roberts, Andrew W., Hallek, Michael, Wierda, William G., Hillmen, Peter, Gerecitano, John F., Cerri, Elisa, Potluri, Jalaja, Kim, Su Young, Busman, Todd, Verdugo, Maria, Humerickhouse, Rod A., Best, Andrea, Desai, Monali, Stilgenbauer, Stephan, Seymour, John F., Davids, Matthew S., Roberts, Andrew W., Hallek, Michael, Wierda, William G., Hillmen, Peter, Gerecitano, John F., Cerri, Elisa, Potluri, Jalaja, Kim, Su Young, Busman, Todd, Verdugo, Maria, Humerickhouse, Rod A., Best, Andrea, Desai, Monali, and Stilgenbauer, Stephan

Published
2016

21. Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia

Author

Konopleva, Marina, primary, Pollyea, Daniel A., additional, Potluri, Jalaja, additional, Chyla, Brenda, additional, Hogdal, Leah, additional, Busman, Todd, additional, McKeegan, Evelyn, additional, Salem, Ahmed Hamed, additional, Zhu, Ming, additional, Ricker, Justin L., additional, Blum, William, additional, DiNardo, Courtney D., additional, Kadia, Tapan, additional, Dunbar, Martin, additional, Kirby, Rachel, additional, Falotico, Nancy, additional, Leverson, Joel, additional, Humerickhouse, Rod, additional, Mabry, Mack, additional, Stone, Richard, additional, Kantarjian, Hagop, additional, and Letai, Anthony, additional

Published
2016
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22. Integrated safety analysis of venetoclax monotherapy in chronic lymphocytic leukemia (CLL).

Author

Davids, Matthew Steven, primary, Gerecitano, John F., additional, Potluri, Jalaja, additional, Cerri, Elisa, additional, Kim, Su Young, additional, Steinberg, Mark, additional, Verdugo, Maria, additional, Busman, Todd A., additional, Enschede, Sari H., additional, Mobasher, Mehrdad, additional, Best, Andrea, additional, Desai, Monali B, additional, and Wierda, William G., additional

Published
2016
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23. Preliminary Results of a Phase 2, Open-Label Study of Venetoclax (ABT-199/GDC-0199) Monotherapy in Patients with Chronic Lymphocytic Leukemia Relapsed after or Refractory to Ibrutinib or Idelalisib Therapy

Author

Jones, Jeffrey, primary, Mato, Anthony R., additional, Coutre, Steven, additional, Wierda, William, additional, Choi, Michael Y., additional, Davids, Matthew S., additional, Lamanna, Nicole, additional, Barr, Paul, additional, Burns, Kim, additional, Montalvo, Nicholas, additional, Zhu, Ming, additional, Busman, Todd, additional, Potluri, Jalaja, additional, Humerickhouse, Rod A., additional, and Byrd, John C., additional

Published
2015
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24. SPECIFIC CRITERIA TO DEFINE A STUDY POPULATION WITH COPD FOR CLINICAL TRIALS IN ACUTE EXACERBATION OF CHRONIC BRONCHITIS

Author

Anzueto, Antonio, Fisher, Chester, Krause, Richard, Palmer, Robert, Busman, Todd, and Olson, Carol Ann

Subjects
Bronchitis -- Care and treatment -- Complications and side effects, Lung diseases, Obstructive -- Care and treatment -- Complications and side effects, Health, Care and treatment, Complications and side effects
Abstract

Antonio Anzueto, MD(*); Chester Fisher, MD,MPH; Richard Krause, MD; Robert Palmer, MPH; Todd Busman, MS and Carol Ann Olson, MD, PhD. Univ of Texas Health Science Center at San Antonio, [...]

Published
2000

25. Safety, Pharmacokinetics, Pharmacodynamics, and Activity of Navitoclax, a Targeted High Affinity Inhibitor of BCL-2, in Lymphoid Malignancies

Author

Wilson, Wyndham H., O’Connor, Owen A., Czuczman, Myron S., LaCasce, Ann S., Gerecitano, John F., Leonard, John P., Tulpule, Anil, Dunleavy, Kieron, Xiong, Hao, Chiu, Yi-Lin, Cui, Yue, Busman, Todd, Elmore, Steven W., Rosenberg, Saul H., Krivoshik, Andrew P., Enschede, Sari H., and Humerickhouse, Rod A.

Subjects
Blood Platelets, Dosage Forms, Sulfonamides, Aniline Compounds, Lymphoma, Maximum Tolerated Dose, T-Lymphocytes, Antineoplastic Agents, Middle Aged, Survival Analysis, Article, Drug Delivery Systems, Proto-Oncogene Proteins c-bcl-2, Humans, Aged
Abstract

Proteins of the BCL-2 family regulate clonal selection and survival of lymphocytes, and are frequently overexpressed in lymphomas. Navitoclax is a targeted high-affinity small molecule that inhibits the anti-apoptotic activity of BCL-2 and BCL-XL. We aimed to assess the safety and antitumour activity of navitoclax in patients with lymphoid tumours, and establish the drug's pharmacokinetic and pharmacodynamic profiles.In this phase 1 dose-escalation study, patients (aged ≥18 years) with relapsed or refractory lymphoid malignancies were enrolled and treated at seven sites in the USA between November, 2006, and November, 2009. A modified Fibonacci 3+3 design was used to assign patients to receive oral navitoclax once daily by one of two dosing schedules: intermittently for the first 14 days of a 21-day cycle (14/21) at doses of 10, 20, 40, 80, 110, 160, 225, 315, or 440 mg/day; or continuously for 21 days of a 21-day cycle (21/21) at doses of 200, 275, 325, or 425 mg/day. Study endpoints were safety, maximum tolerated dose, pharmacokinetic profile, pharmacodynamic effects on platelets and T cells, and antitumour activity. This trial is registered with ClinicalTrials.gov, number NCT00406809.55 patients were enrolled (median age 59 years, IQR 51-67), 38 to receive the 14/21 dosing schedule, and 17 to receive the 21/21 dosing schedule. Common toxic effects included grade 1 or 2 anaemia (41 patients), infection (39), diarrhoea (31), nausea (29), and fatigue (21); and grade 3 or 4 thrombocytopenia (29), lymphocytopenia (18), and neutropenia (18). On the intermittent 14/21 schedule, dose-limiting toxic effects were hospital admissions for bronchitis (one) and pleural effusion (one), grade 3 increase in aminotransferases (one), grade 4 thrombocytopenia (one), and grade 3 cardiac arrhythmia (one). To reduce platelet nadir associated with intermittent 14/21 dosing, we assessed a 150 mg/day lead-in dose followed by a continuous 21/21 dosing schedule. On the 21/21 dosing schedule, two patients did not complete the first cycle and were excluded from assessment of dose-limiting toxic effects; dose-limiting toxic effects were grade 4 thrombocytopenia (one), grade 3 increase in aminotransferases (one), and grade 3 gastrointestinal bleeding (one). Navitoclax showed a pharmacodynamic effect on circulating platelets and T cells. Clinical responses occurred across the range of doses and in several tumour types. Ten of 46 patients with assessable disease had a partial response, and these responders had median progression-free survival of 455 days (IQR 40-218).Navitoclax has a novel mechanism of peripheral thrombocytopenia and T-cell lymphopenia, attributable to high-affinity inhibition of BCL-XL and BCL-2, respectively. On the basis of these findings, a 150 mg 7-day lead-in dose followed by a 325 mg dose administered on a continuous 21/21 dosing schedule was selected for phase 2 study.Abbott Laboratories, Genentech, and National Cancer Institute, National Institutes of Health.

Published
2010

26. Phase 1 study of the safety, pharmacokinetics, and antitumour activity of the BCL2 inhibitor navitoclax in combination with rituximab in patients with relapsed or refractory CD20+lymphoid malignancies

Author

Roberts, Andrew W., primary, Advani, Ranjana H., additional, Kahl, Brad S., additional, Persky, Daniel, additional, Sweetenham, John W., additional, Carney, Dennis A., additional, Yang, Jianning, additional, Busman, Todd B., additional, Enschede, Sari H., additional, Humerickhouse, Roderick A., additional, and Seymour, John F., additional

Published
2015
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27. A Phase 2 Study of ABT-199 (GDC-0199) in Patients with Acute Myelogenous Leukemia (AML)

Author

Konopleva, Marina, primary, Pollyea, Daniel A., additional, Potluri, Jalaja, additional, Chyla, Brenda J., additional, Busman, Todd, additional, McKeegan, Evelyn, additional, Salem, Ahmed, additional, Zhu, Ming, additional, Ricker, Justin L., additional, Blum, William, additional, DiNardo, Courtney D., additional, Dunbar, Martin, additional, Kirby, Rachel, additional, Falotico, Nancy, additional, Leverson, Joel D., additional, Humerickhouse, Rod A., additional, Mabry, Mack, additional, Stone, Richard M., additional, Kantarjian, Hagop M., additional, and Letai, Anthony G., additional

Published
2014
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28. The Single-Agent Bcl-2 Inhibitor ABT-199 (GDC-0199) In Patients With Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL): Responses Observed In All Mantle Cell Lymphoma (MCL) Patients

Author

Davids, Matthew S., primary, Seymour, John F., additional, Gerecitano, John F., additional, Kahl, Brad S., additional, Pagel, John M., additional, Wierda, William G., additional, Anderson, Mary-Ann, additional, Rudersdorf, Nikita K., additional, Gressick, Lori A., additional, Montalvo, Nicholas P., additional, Yang, Jianning, additional, Busman, Todd A., additional, Dunbar, Martin, additional, Cerri, Elisa, additional, Enschede, Sari H., additional, Humerickhouse, Rod A., additional, and Roberts, Andrew W., additional

Published
2013
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29. Updated results of a phase I first-in-human study of the BCL-2 inhibitor ABT-199 (GDC-0199) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Author

Seymour, John Francis, primary, Davids, Matthew Steven, additional, Pagel, John M., additional, Kahl, Brad S., additional, Wierda, William G., additional, Miller, Thomas P., additional, Gerecitano, John F., additional, Kipps, Thomas J., additional, Anderson, Mary Ann, additional, Huang, David C.S., additional, Darden, David E., additional, Gressick, Lori A., additional, Nolan, Cathy E., additional, Yang, Jianning, additional, Busman, Todd A., additional, Graham, Alison M., additional, Cerri, Elisa, additional, Enschede, Sari H., additional, Humerickhouse, Rod A., additional, and Roberts, Andrew Warwick, additional

Published
2013
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30. Updated results of a phase I first-in-human study of the BCL-2 inhibitor ABT-199 (GDC-0199) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).

Author

Davids, Matthew Steven, primary, Seymour, John Francis, additional, Gerecitano, John F., additional, Kahl, Brad S., additional, Pagel, John M., additional, Wierda, William G., additional, Anderson, Mary Ann, additional, Darden, David E., additional, Nolan, Cathy E., additional, Gressick, Lori A., additional, Yang, Jianning, additional, Chyla, Brenda J., additional, Busman, Todd A., additional, Graham, Alison M., additional, Cerri, Elisa, additional, Enschede, Sari H., additional, Humerickhouse, Rod A., additional, and Roberts, Andrew W, additional

Published
2013
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31. The BCL-2-Specific BH3-Mimetic ABT-199 (GDC-0199) Is Active and Well-Tolerated in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Interim Results of a Phase I First-in-Human Study

Author

Seymour, John F., primary, Davids, Matthew S., additional, Anderson, Mary Ann, additional, Kipps, Thomas J., additional, Wierda, William G., additional, Pagel, John M., additional, Kahl, Brad S., additional, Miller, Thomas P., additional, Darden, David E., additional, Nolan, Cathy E., additional, Gressick, Lori A., additional, Xiong, Hao, additional, Huang, David C.S., additional, Chyla, Brenda J., additional, Busman, Todd A., additional, Graham, Alison M., additional, Cerri, Elisa, additional, Enschede, Sari H., additional, Humerickhouse, Rod A., additional, and Roberts, Andrew W., additional

Published
2012
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32. The BCL-2-Specific BH3-Mimetic ABT-199 (GDC-0199) Is Active and Well-Tolerated in Patients with Relapsed Non-Hodgkin Lymphoma: Interim Results of a Phase I Study

Author

Davids, Matthew S., primary, Roberts, Andrew W., additional, Anderson, Mary Ann, additional, Pagel, John M., additional, Kahl, Brad S., additional, Gerecitano, John F., additional, Darden, David E., additional, Nolan, Cathy E., additional, Gressick, Lori A., additional, Yang, Jianning, additional, Chyla, Brenda J., additional, Busman, Todd A., additional, Graham, Alison M., additional, Cerri, Elisa, additional, Enschede, Sari H., additional, Humerickhouse, Rod A., additional, and Seymour, John F., additional

Published
2012
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33. Phase II Study of Single-Agent Navitoclax (ABT-263) and Biomarker Correlates in Patients with Relapsed Small Cell Lung Cancer

Author

Rudin, Charles M., primary, Hann, Christine L., additional, Garon, Edward B., additional, Ribeiro de Oliveira, Moacyr, additional, Bonomi, Philip D., additional, Camidge, D. Ross, additional, Chu, Quincy, additional, Giaccone, Giuseppe, additional, Khaira, Divis, additional, Ramalingam, Suresh S., additional, Ranson, Malcolm R., additional, Dive, Caroline, additional, McKeegan, Evelyn M., additional, Chyla, Brenda J., additional, Dowell, Barry L., additional, Chakravartty, Arunava, additional, Nolan, Cathy E., additional, Rudersdorf, Niki, additional, Busman, Todd A., additional, Mabry, Mack H., additional, Krivoshik, Andrew P., additional, Humerickhouse, Rod A., additional, Shapiro, Geoffrey I., additional, and Gandhi, Leena, additional

Published
2012
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34. Substantial Susceptibility of Chronic Lymphocytic Leukemia to BCL2 Inhibition: Results of a Phase I Study of Navitoclax in Patients With Relapsed or Refractory Disease

Author

Roberts, Andrew W., primary, Seymour, John F., additional, Brown, Jennifer R., additional, Wierda, William G., additional, Kipps, Thomas J., additional, Khaw, Seong Lin, additional, Carney, Dennis A., additional, He, Simon Z., additional, Huang, David C.S., additional, Xiong, Hao, additional, Cui, Yue, additional, Busman, Todd A., additional, McKeegan, Evelyn M., additional, Krivoshik, Andrew P., additional, Enschede, Sari H., additional, and Humerickhouse, Rod, additional

Published
2012
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35. Navitoclax (ABT-263) Plus Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR): A Phase 1 Study in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL),

Author

Kipps, Thomas J., primary, Swinnen, Lode J., additional, Wierda, William G., additional, Jones, Jeffrey Alan, additional, Coutre, Steven E., additional, Smith, Mitchell R, additional, Yang, Jianning, additional, Cui, Yue, additional, Busman, Todd, additional, Enschede, Sari, additional, and Humerickhouse, Rod, additional

Published
2011
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36. Abstract A92: A phase 1 safety and pharmacokinetic study of navitoclax in combination with docetaxel in patients with solid tumors.

Author

Eskens, Ferry ALM, primary, Gutierrez, Martin, additional, Cosgrove, David, additional, Puglisi, Martina, additional, van Doorn, Leni, additional, Blanco, Montserrat, additional, de Jonge, Maja JA, additional, Moran, Kirsty, additional, Walther, Axel, additional, Yang, Jianning, additional, Busman, Todd A., additional, Franklin, Catherine A., additional, Mabry, Mack H., additional, Humerickhouse, Rod A., additional, and Molife, Lulama Rhoda, additional

Published
2011
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37. Abstract A93: Safety, efficacy and pharmacokinetics of two schedules of navitoclax (ABT-263) in combination with irinotecan: Preliminary results of an open-label phase 1 study.

Author

Tolcher, Anthony W., primary, LoRusso, Patricia, additional, Rosen, Lee, additional, de Oliveira, Moacyr Ribeiro, additional, Waring, Jeffrey F., additional, Rudersdorf, Niki, additional, Patel, Raina, additional, Brasher, Carol Ann, additional, Busman, Todd, additional, Cui, Yue, additional, Yang, Jianning, additional, and Holen, Kyle, additional

Published
2011
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38. 5.23 Phase 2 Study of Navitoclax (ABT-263) Safety and Efficacy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Interim Results

Author

Seymour, John F., primary, Roberts, Andrew W., additional, Carney, Dennis A., additional, Dyer, Martin J.S., additional, Kipps, Thomas J., additional, Hallek, Michael, additional, Bociek, R. Gregory, additional, Brown, Jennifer R., additional, Wierda, William G., additional, Rai, Kanti, additional, Ribeiro de Oliveira, Moacyr, additional, McKeegan, Evelyn, additional, Chyla, Brenda, additional, Busman, Todd, additional, Krivoshik, Andrew, additional, Enschede, Sari, additional, and Humerickhouse, Rod, additional

Published
2011
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39. Phase I Study of Navitoclax (ABT-263), a Novel Bcl-2 Family Inhibitor, in Patients With Small-Cell Lung Cancer and Other Solid Tumors

Author

Gandhi, Leena, primary, Camidge, D. Ross, additional, Ribeiro de Oliveira, Moacyr, additional, Bonomi, Philip, additional, Gandara, David, additional, Khaira, Divis, additional, Hann, Christine L., additional, McKeegan, Evelyn M., additional, Litvinovich, Elizabeth, additional, Hemken, Philip M., additional, Dive, Caroline, additional, Enschede, Sari H., additional, Nolan, Cathy, additional, Chiu, Yi-Lin, additional, Busman, Todd, additional, Xiong, Hao, additional, Krivoshik, Andrew P., additional, Humerickhouse, Rod, additional, Shapiro, Geoffrey I., additional, and Rudin, Charles M., additional

Published
2011
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41. Navitoclax (ABT-263) Plus Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR): A Phase 1 Study In Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Author

Kipps, Thomas J., primary, Wierda, William G., additional, Jones, Jeffrey A., additional, Swinnen, Lode J., additional, Yang, Jianning, additional, Cui, Yue, additional, Busman, Todd, additional, Krivoshik, Andrew, additional, Enschede, Sari, additional, and Humerickhouse, Rod, additional

Published
2010
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42. An Ongoing Phase 1/2a Study of ABT-263; Pharmacokinetics (PK), Safety and Anti-Tumor Activity in Patients (pts) with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).

Author

Roberts, Andrew W., primary, Seymour, John F, additional, Brown, Jennifer R, additional, Wierda, William G, additional, Kipps, Thomas J., additional, Carney, Dennis, additional, Xiong, Hao, additional, Cui, Yue, additional, Busman, Todd, additional, Enschede, Sari, additional, Krivoshik, Andrew, additional, and Humerickhouse, Rod, additional

Published
2009
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43. Phase 1/2a Study of ABT-263 in Relapsed or Refractory Lymphoid Malignancies.

Author

Wilson, Wyndham H, primary, O'Connor, Owen A, additional, Czuczman, Myron S, additional, LaCasce, Ann, additional, Gerecitano, John, additional, Leonard, John P., additional, Tulpule, Anil, additional, Xiong, Hao, additional, Chiu, Yi-Lin, additional, Busman, Todd, additional, Enschede, Sari, additional, Krivoshik, Andrew, additional, and Humerickhouse, Rod, additional

Published
2009
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44. An Ongoing Phase 1 Study of ABT-263; Pharmacokinetics, Safety and Anti-Tumor Activity in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Author

Roberts, Andrew W., primary, Brown, Jennifer, primary, Seymour, John F., primary, Wierda, William G., primary, Kipps, Thomas J., primary, Xiong, Hao, primary, Chiu, Yi-Lin, primary, Busman, Todd, primary, Knight, Raymond A., primary, Enschede, Sari, primary, Krivoshik, Andrew, primary, and Humerickhouse, Rod, primary

Published
2008
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45. Phase 1 Study of ABT-263, a Bcl-2 Family Inhibitor, in Relapsed or Refractory Lymphoid Malignancies.

Author

Wilson, Wyndham H, primary, O’Connor, O., primary, Czuczman, Myron S., primary, LaCasce, Ann, primary, Gerecitano, J., primary, Leonard, John P., primary, Tulpule, Anil, primary, Xiong, Hao, primary, Chiu, Yi-Lin, primary, Busman, Todd, primary, Knight, Raymond A., primary, Enschede, Sari, primary, Krivoshik, Andrew, primary, and Humerickhouse, Rod, primary

Published
2008
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47. Phase 1 study of the safety, pharmacokinetics, and antitumour activity of the BCL2 inhibitor navitoclax in combination with rituximab in patients with relapsed or refractory CD20+ lymphoid malignancies.

Author

Roberts, Andrew W., Advani, Ranjana H., Kahl, Brad S., Persky, Daniel, Sweetenham, John W., Carney, Dennis A., Yang, Jianning, Busman, Todd B., Enschede, Sari H., Humerickhouse, Roderick A., and Seymour, John F.

Subjects
LYMPHOCYTIC leukemia, COMBINATION drug therapy, PHARMACOKINETICS, MEDICATION safety, RITUXIMAB, ANTINEOPLASTIC agents, DISEASE relapse, LEUKEMIA treatment
Abstract

The oral BCL2 inhibitor navitoclax has moderate single-agent efficacy in chronic lymphocytic leukaemia ( CLL) and minor activity in lymphoma in Phase 1 trials. Navitoclax synergizes with rituximab in preclinical models of B-cell lymphoid cancers. We report the safety, pharmacokinetics and clinical activity of this combination. Patients received navitoclax (200-325 mg) daily and four standard weekly doses of rituximab. Twenty-nine patients were enrolled across three dose-escalation cohorts and a safety expansion cohort (250 mg/d navitoclax). The combination was well tolerated. Common toxicities were mild diarrhoea (79%) and nausea (72%). Grade 4 thrombocytopenia occurred in 17% of patients (dose limiting at 325 mg/d). CD19+ counts were severely reduced, while CD3+ cells ( ~ 20%) and serum immunoglobulin M levels ( ~ 33%) were also reduced during the first year. The maximum tolerated dose for navitoclax in combination was 250 mg/d. Pharmacokinetic analyses revealed no apparent interactions between the drugs. The response rate in patients with follicular lymphoma was 9/12, including five complete responses. All five patients with CLL/small lymphocytic leukaemia achieved partial responses. One of nine patients with aggressive lymphoma responded. The addition of rituximab to navitoclax 250 mg/d is safe; the combination demonstrates higher response rates for low-grade lymphoid cancers than observed for either agent alone in previous Phase 1 trials. [ABSTRACT FROM AUTHOR]

Published
2015
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