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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 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 82 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01685892
The ClinicalTrials.gov registry entry for NCT01685892 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT01685892 reports 0 study locations.
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.
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