A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03797261|
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : May 17, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797261
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, California|
|City of Hope /ID# 207393||Recruiting|
|Duarte, California, United States, 91010|
|USC Norris Cancer Center /ID# 207396||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Sylvester Comprehensive Cancer /ID# 209250||Not yet recruiting|
|Miami, Florida, United States, 33136-1002|
|United States, Iowa|
|University of Iowa Hospitals and Clinics /ID# 207459||Not yet recruiting|
|Iowa City, Iowa, United States, 52242|
|United States, Kansas|
|Univ Kansas Med Ctr /ID# 207480||Not yet recruiting|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Dana-Farber Cancer Institute /ID# 207367||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University-School of Medicine /ID# 206995||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Langone Medical Center /ID# 207390||Not yet recruiting|
|New York, New York, United States, 10016-6402|
|United States, North Carolina|
|Unc /Id# 207388||Not yet recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|UPMC Hillman Cancer Ctr /ID# 208482||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Australia, New South Wales|
|Calvary Mater Newcastle /ID# 211455||Not yet recruiting|
|Waratah, New South Wales, Australia, 2298|
|Australia, South Australia|
|Royal Adelaide Hospital /ID# 210602||Not yet recruiting|
|Adelaide, South Australia, Australia, 5000|
|St. Vincents Hosp Melbourne /ID# 210601||Not yet recruiting|
|Fitzroy, Victoria, Australia, 3065|
|Alfred Hospital /ID# 210350||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|
|Box Hill Hospital /ID# 210599||Not yet recruiting|
|Melbourne, Victoria, Australia, 3128|
|Universitaetsklinikum Leipzig /ID# 209824||Not yet recruiting|
|Leipzig, Sachsen, Germany, 04103|
|Charite Universitatsmedizin B- /ID# 207987||Not yet recruiting|
|Berlin, Germany, 13353|
|Universitaetklinikum Dresden /ID# 207803||Not yet recruiting|
|Dresden, Germany, 01307|
|Universitaetsklinikum Frankfur /ID# 207984||Not yet recruiting|
|Frankfurt, Germany, 60590|
|Univ Klinik Eppendorf Hamburg /ID# 207788||Not yet recruiting|
|Hamburg, Germany, 20246|
|Study Director:||AbbVie Inc.||AbbVie|