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NCT01773408 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT01773408: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01773408 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01773408, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Daunorubicin
- DRUG RO5503781 MBP
- DRUG RO5503781 SDP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01773408 record still lists
NCT01773408 is an interventional study that assigns participants to a tested intervention. The registered 122 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 (103% higher).
The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.
NCT01773408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01773408 about?
NCT01773408 is a clinical study titled "A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia". This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and i...
What is the current status of trial NCT01773408?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2013-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01773408?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin (DRUG), RO5503781 MBP (DRUG), RO5503781 SDP (DRUG).
Who is sponsoring clinical trial NCT01773408?
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 NCT01773408's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 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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