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NCT01685892 · ClinicalTrials.gov registry record · Phase 1
A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT01685892: Completed Phase 1 study, sponsored by Genentech.
NCT01685892 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01685892, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab).
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2012-11-29 |
| Est. Completion | 2019-08-23 |
| Phase | Phase 1 |
What the finished NCT01685892 record still lists
NCT01685892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT01685892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01685892 about?
NCT01685892 is a clinical study titled "A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia". This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leu...
What is the current status of trial NCT01685892?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2012-11-29. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT01685892?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG).
Who is sponsoring clinical trial NCT01685892?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01685892's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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