Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
Have a question?
You can ask us questions via online form or phone call.
Call us @: 844 663-3742
| Location | Status | Site Contact Details |
|---|---|---|
Location City of Hope, Duarte, California, 91010 | Status Not Available | |
Location University of California, Davis Comprehensive Cancer Center, Sacramento, California, 95817 | Status Not Available | |
Location Univ of Colorado Cancer Center, Aurora, Colorado, 80045 | Status Not Available | |
Location Emory Midtown Infectious Disease Clinic, Atlanta, Georgia, 30322 | Status Not Available | |
Location Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611-2927 | Status Not Available | |
Location The University of Chicago Medical Center, Chicago, Illinois, 60637-1443 | Status Not Available | |
Location Johns Hopkins University, Baltimore, Maryland, 21287 | Status Not Available | |
Location Dana-Farber Cancer Institute, Boston, Massachusetts, 02215 | Status Not Available | |
Location Columbia University Medical Center, New York, New York, 10032-3729 | Status Not Available | |
Location Duke Cancer Center, Durham, North Carolina, 27710-3000 | Status Not Available | |
Location University of Texas MD Anderson Cancer Center, Houston, Texas, 77030 | Status Not Available | |
Location University of Texas MD Anderson Cancer Center, Houston, Texas, 77030 | Status Not Available | |
Location University of Washington, Seattle, Washington, 98109 | Status Not Available |
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole.
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Measured up to 1 year after the last subject last dose
Maximum observed plasma concentration (Cmax)
Time Frame: For approximately 5 days following a single dose of ABT-199.
Time to Cmax (peak time, Tmax),
Time Frame: For approximately 5 days following a single dose of ABT-199.
The area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC0-24)
Time Frame: For approximately 5 days following a single dose of ABT-199.
Half-Life (t1/2)
Time Frame: For approximately 5 days following a single dose of ABT-199.
Clearance (CL)
Time Frame: For approximately 5 days following a single dose of ABT-199.
Complete Remission Rate
Time Frame: Measured up to 1 year after the last subject last dose
Complete Remission with incomplete blood count recovery rate
Time Frame: Measured up to 1 year after the last subject last dose
Overall Response Rate
Time Frame: Measured up to 1 year after the last subject last dose
Overall Survival
Time Frame: Measured up to 1 year after the last subject last dose
Event Free Survival
Time Frame: Measured up to 1 year after the last subject last dose
Duration of Response
Time Frame: Measured up to 1 year after the last subject last dose
Interventions:
- Drug: Posaconazole
- Drug: ABT-199
- Drug: ABT-199
- Drug: ABT-199
- Drug: Decitabine
- Drug: Decitabine
- Drug: Azacitidine
Enrollment:
212
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
Watch a video to learn more about what you may experience as a clinical trial volunteer: /resources/what-happens-in-a-clinical-trial
Take a virtual reality screening visit tour to an example of a clinical trial site: /resources/screening-visit-virtual-tour
Use a questionnaire tool to think through questions to ask yourself about participating in a clinical trial and print out your responses to discuss with your partners in your health journey: /resource-information-clinical-trial-community/decision-counselor