A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
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ClinicalTrials.gov Identifier: NCT03797261 |
Recruitment Status :
Suspended
(Safety)
First Posted : January 9, 2019
Last Update Posted : December 17, 2020
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Sponsor:
AbbVie
Collaborators:
Genentech, Inc.
Amgen
Information provided by (Responsible Party):
AbbVie
Tracking Information | |||||||
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First Submitted Date ICMJE | January 7, 2019 | ||||||
First Posted Date ICMJE | January 9, 2019 | ||||||
Last Update Posted Date | December 17, 2020 | ||||||
Actual Study Start Date ICMJE | March 18, 2019 | ||||||
Estimated Primary Completion Date | September 2, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies | ||||||
Official Title ICMJE | Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies | ||||||
Brief Summary | This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL). This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Venetoclax + AMG 176
Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Suspended | ||||||
Estimated Enrollment ICMJE |
86 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | September 2, 2022 | ||||||
Estimated Primary Completion Date | September 2, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Germany, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03797261 | ||||||
Other Study ID Numbers ICMJE | M16-785 2018-003314-41 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | AbbVie | ||||||
Study Sponsor ICMJE | AbbVie | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | AbbVie | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |