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NCT01414205 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT01414205 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 80 participants.
The verdict
NCT01414205, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.
Interventions
- DRUG Obinutuzumab
- DRUG Corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2016-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01414205
The ClinicalTrials.gov registry entry for NCT01414205 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 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.
NCT01414205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01414205 about?
NCT01414205 is a clinical study titled "A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)". This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (100...
What is the current status of trial NCT01414205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2011-10-31. Estimated completion is 2016-03-31.
What interventions are being tested in trial NCT01414205?
The interventions under investigation include: Obinutuzumab (DRUG), Corticosteroids (DRUG).
Who is sponsoring clinical trial NCT01414205?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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