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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR VENETOCLAX

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Clinical Trials for Venetoclax

Trial ID Title Status Sponsor Phase Summary
NCT01671904 A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) Recruiting AbbVie (prior sponsor, Abbott) Phase 1 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with relapsed/refractory or previously untreated CLL. The study will explore two schedules for drug administration, Schedule A (venetoclax introduced before other agents) and Schedule B (introduced after other agents). In addition, the study will explore two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.
NCT01671904 A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) Recruiting Genentech, Inc. Phase 1 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with relapsed/refractory or previously untreated CLL. The study will explore two schedules for drug administration, Schedule A (venetoclax introduced before other agents) and Schedule B (introduced after other agents). In addition, the study will explore two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.
NCT01682616 A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Active, not recruiting Genentech, Inc. Phase 1 This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, subjects may re-initiate ABT-199.
NCT01682616 A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Active, not recruiting AbbVie (prior sponsor, Abbott) Phase 1 This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, subjects may re-initiate ABT-199.
NCT01685892 A Study of Venetoclax (GDC-0199; ABT-199) in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia Active, not recruiting AbbVie (prior sponsor, Abbott) Phase 1 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia. All participants (relapsed/refractory and previously untreated) will receive 6 cycles of obinutuzumab and venetoclax. After completing combination treatment, previously untreated participants will receive single agent venetoclax for at least 6 additional months (the anticipated time on treatment for previously untreated participants is at least 12 months). After completing combination treatment, relapsed/refractory participants will continue single agent venetoclax until disease progression.
NCT01685892 A Study of Venetoclax (GDC-0199; ABT-199) in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia Active, not recruiting Genentech, Inc. Phase 1 This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia. All participants (relapsed/refractory and previously untreated) will receive 6 cycles of obinutuzumab and venetoclax. After completing combination treatment, previously untreated participants will receive single agent venetoclax for at least 6 additional months (the anticipated time on treatment for previously untreated participants is at least 12 months). After completing combination treatment, relapsed/refractory participants will continue single agent venetoclax until disease progression.
NCT01794520 Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma Recruiting Genentech, Inc. Phase 1 The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in subjects with relapsed or refractory multiple myeloma. This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in subjects with t(11;14)-positive multiple myeloma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Venetoclax

Condition Name

Condition Name for Venetoclax
Intervention Trials
Chronic Lymphocytic Leukemia 17
Acute Myeloid Leukemia 9
Small Lymphocytic Lymphoma 7
Acute Myeloid Leukemia (AML) 6
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Condition MeSH

Condition MeSH for Venetoclax
Intervention Trials
Leukemia 54
Leukemia, Lymphoid 35
Lymphoma 32
Leukemia, Lymphocytic, Chronic, B-Cell 31
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Clinical Trial Locations for Venetoclax

Trials by Country

Trials by Country for Venetoclax
Location Trials
United States 226
Australia 19
Japan 14
Germany 13
France 13
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Trials by US State

Trials by US State for Venetoclax
Location Trials
Texas 22
California 19
Massachusetts 16
Ohio 15
New York 13
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Clinical Trial Progress for Venetoclax

Clinical Trial Phase

Clinical Trial Phase for Venetoclax
Clinical Trial Phase Trials
Phase 3 12
Phase 2 34
Phase 1/Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Venetoclax
Clinical Trial Phase Trials
Not yet recruiting 49
Recruiting 47
Active, not recruiting 4
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Clinical Trial Sponsors for Venetoclax

Sponsor Name

Sponsor Name for Venetoclax
Sponsor Trials
AbbVie 36
Genentech, Inc. 17
National Cancer Institute (NCI) 14
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Sponsor Type

Sponsor Type for Venetoclax
Sponsor Trials
Industry 87
Other 70
NIH 14
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Federal Trade Commission
Chubb
Citi
Colorcon
Dow
Medtronic
Fish and Richardson
Chinese Patent Office
Harvard Business School

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