Trials / Completed
CompletedNCT01349049
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia (AML)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Protocol PLX108-05 is a Phase 1/2 open-label, sequential dose escalation (Part 1) followed by cohort expansion (Part 2) design at the recommended phase 2 dose established in Part 1 (i.e. 3,000 mg/day). Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity, disease progression or relapse, patient death, Investigator decision, or voluntary withdrawal.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLX3397 | Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily. |
| DRUG | PLX3397 | The drug product is available in capsule form, to be taken orally. |
Timeline
- Start date
- 2011-11-21
- Primary completion
- 2015-01-20
- Completion
- 2018-01-09
- First posted
- 2011-05-06
- Last updated
- 2020-03-02
- Results posted
- 2019-11-21
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01349049. Inclusion in this directory is not an endorsement.