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NCT03236857 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
NCT03236857: Completed Phase 1 study, sponsored by AbbVie.
NCT03236857 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 143 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03236857, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
Study Summary
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
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.
Interventions
- DRUG venetoclax
- DRUG chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2023-04-19 |
| Phase | Phase 1 |
What the finished NCT03236857 record still lists
NCT03236857 is an interventional study that assigns participants to a tested intervention. The registered 143 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 (138% higher).
The record links to 0 conditions, and to 2 interventions - of which venetoclax is the first listed.
NCT03236857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03236857 about?
NCT03236857 is a clinical study titled "A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies". An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with ...
What is the current status of trial NCT03236857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2017-11-08. Estimated completion is 2023-04-19.
What interventions are being tested in trial NCT03236857?
The interventions under investigation include: venetoclax (DRUG), chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03236857?
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 NCT03236857's enrollment target sits among peer trials
143 401st of 2000 higher than 1,600 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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