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NCT01349049 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT01349049 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 90 participants.
The verdict
NCT01349049, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.
Interventions
- DRUG PLX3397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2011-11-21 |
| Est. Completion | 2018-01-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01349049
The ClinicalTrials.gov registry entry for NCT01349049 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PLX3397 is the first listed.
NCT01349049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01349049 about?
NCT01349049 is a clinical study titled "Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)". The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on sa...
What is the current status of trial NCT01349049?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2011-11-21. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT01349049?
The interventions under investigation include: PLX3397 (DRUG).
Who is sponsoring clinical trial NCT01349049?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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