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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 122 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01773408
The ClinicalTrials.gov registry entry for NCT01773408 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.
NCT01773408 reports 0 study locations.
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.
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