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NCT02203773 · ClinicalTrials.gov registry record · Phase 1
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
A Phase 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 212
- Enrollment target
NCT02203773: Clinical Trial Phase 1 study, sponsored by AbbVie.
NCT02203773 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 212 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (253% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02203773, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 212 participants
- Enrollment target
Study 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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Interventions
- DRUG Azacitidine
- DRUG Decitabine
- DRUG Posaconazole
- DRUG ABT-199
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2022-06-16 |
| Phase | Phase 1 |
Why NCT02203773 stopped before completion
NCT02203773 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (253% higher).
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT02203773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02203773 about?
NCT02203773 is a clinical study titled "Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)". 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) su...
What is the current status of trial NCT02203773?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 212 participants. The study started on 2014-10-06. Estimated completion is 2022-06-16.
What interventions are being tested in trial NCT02203773?
The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), Posaconazole (DRUG), ABT-199 (DRUG).
Who is sponsoring clinical trial NCT02203773?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203773's enrollment target sits among peer trials
212 245th of 2000 higher than 1,756 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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