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NCT02287233 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT02287233 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 94 participants.
The verdict
NCT02287233, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve participants with acute myelogenous leukemia (AML); and a Phase 2 part that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.
Interventions
- DRUG Venetoclax
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2014-12-31 |
| Est. Completion | 2021-08-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02287233
The ClinicalTrials.gov registry entry for NCT02287233 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT02287233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02287233 about?
NCT02287233 is a clinical study titled "A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia". This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatmen...
What is the current status of trial NCT02287233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2014-12-31. Estimated completion is 2021-08-10.
What interventions are being tested in trial NCT02287233?
The interventions under investigation include: Venetoclax (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT02287233?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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