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 (Suspended to evaluate safety)
First Posted : January 9, 2019
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Diffuse Large B-cell Lymphoma||Drug: Venetoclax Drug: AMG 176||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||September 2, 2022|
|Estimated Study Completion Date :||September 2, 2022|
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.
Other Name: ABT-199
Drug: AMG 176
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176 [ Time Frame: Up to 28 days after first dose of study drug in a dose-escalation phase ]The MTD and/or RPTD of venetoclax and of AMG 176 will be determined during the dose escalation phase of the study.
- Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years). ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Composite Complete Remission Rate (CRc) for Participants with AML [ Time Frame: Up to approximately 2 years from last subject first dose ]CRc rate is defined as CR + CRi (CR with incomplete blood count recovery).
- Objective Response Rate (ORR) for Participants with AML [ Time Frame: Up to approximately 2 years from last subject first dose ]ORR is defined as the percentage of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on International Working Group (IWG) criteria for AML
- ORR for Participants with NHL [ Time Frame: Up to approximately 2 years from last subject first dose ]ORR is defined as the percentage of participants with documented CR + PR based on Lugano criteria for NHL.
- Maximum Plasma Concentration (Cmax) of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]Maximum observed plasma concentration (Cmax) of venetoclax.
- Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]Time to maximum plasma concentration (Tmax) of Venetoclax.
- AUC of Venetoclax [ Time Frame: Up to approximately 28 days after first dose of study drug ]Area under the plasma concentration-time curve (AUC) of venetoclax.
- Maximum Plasma Concentration (Cmax) of AMG 176 [ Time Frame: Up to approximately 16 days after first dose of study drug ]Maximum observed plasma concentration (Cmax) of AMG 176
- Half-life (t1/2) of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]Terminal phase elimination half-life (t1/2)
- AUC of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]Area Under the Plasma Concentration-time Curve (AUC) of AMG 176
- Clearance (CL) of AMG 176 [ Time Frame: Approximately 16 days after first dose of study drug ]Clearance (CL) is defined the volume of plasma cleared of the drug per unit time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797261
|United States, California|
|City of Hope /ID# 207393|
|Duarte, California, United States, 91010|
|USC Norris Cancer Center /ID# 207396|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Miami Cancer Institute - Baptist Health South Florida /ID# 209825|
|Miami, Florida, United States, 33176|
|United States, Iowa|
|University of Iowa Hospitals and Clinics /ID# 207459|
|Iowa City, Iowa, United States, 52242|
|United States, Kansas|
|Univ Kansas Med Ctr /ID# 207480|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Dana-Farber Cancer Institute /ID# 207367|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University-School of Medicine /ID# 206995|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Langone Medical Center /ID# 207390|
|New York, New York, United States, 10016-6402|
|United States, North Carolina|
|Unc /Id# 207388|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|UPMC Hillman Cancer Ctr /ID# 208482|
|Pittsburgh, Pennsylvania, United States, 15232|
|Australia, New South Wales|
|Calvary Mater Newcastle /ID# 211455|
|Waratah, New South Wales, Australia, 2298|
|Australia, South Australia|
|Royal Adelaide Hospital /ID# 210602|
|Adelaide, South Australia, Australia, 5000|
|St. Vincents Hosp Melbourne /ID# 210601|
|Fitzroy, Victoria, Australia, 3065|
|Alfred Hospital /ID# 210350|
|Melbourne, Victoria, Australia, 3004|
|Box Hill Hospital /ID# 210599|
|Melbourne, Victoria, Australia, 3128|
|Universitaetsklinikum Leipzig /ID# 209824|
|Leipzig, Sachsen, Germany, 04103|
|Charite Universitatsmedizin B- /ID# 207987|
|Berlin, Germany, 13353|
|Universitaetklinikum Dresden /ID# 207803|
|Dresden, Germany, 01307|
|Universitaetsklinikum Frankfurt /ID# 207984|
|Frankfurt, Germany, 60590|
|Univ Klinik Eppendorf Hamburg /ID# 207788|
|Hamburg, Germany, 20246|
|Study Director:||AbbVie Inc.||AbbVie|