Trials / Terminated
TerminatedNCT02203773
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole | Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28. |
| DRUG | ABT-199 | ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change. |
| DRUG | Decitabine | Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles |
| DRUG | Azacitidine | Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles. |
Timeline
- Start date
- 2014-10-06
- Primary completion
- 2022-06-16
- Completion
- 2022-06-16
- First posted
- 2014-07-30
- Last updated
- 2023-05-16
Locations
23 sites across 4 countries: United States, Australia, France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02203773. Inclusion in this directory is not an endorsement.