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NCT01635296 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01635296: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01635296 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635296, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.
Interventions
- DRUG cytarabine
- DRUG RO5045377
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01635296 record still lists
NCT01635296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which cytarabine is the first listed.
NCT01635296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01635296 about?
NCT01635296 is a clinical study titled "A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia". This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will rece...
What is the current status of trial NCT01635296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01635296?
The interventions under investigation include: cytarabine (DRUG), RO5045377 (DRUG).
Who is sponsoring clinical trial NCT01635296?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01635296's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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