Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL
Phase 2
Completed
- Conditions
- Acute Promyelocytic Leukemia
- Registration Number
- NCT00520208
- Lead Sponsor
- CytRx
- Brief Summary
This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who are intolerant to either drug are eligible for this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. Minimum 28 days
- Secondary Outcome Measures
Name Time Method (1) To determine the rates of morphologic leukemia-free state, partial response, cytogenetic complete response, and molecular complete response for tamibarotene therapy in the indicated patient population. Minimum 28 days (2) To determine the safety profile and tolerability of tamibarotene in the indicated patient population. Up to 32 weeks (3) To determine the pharmacokinetic (PK) profile of tamibarotene when administered in the indicated patient population. One year
Trial Locations
- Locations (2)
Northwestern University
🇺🇸Chicago, Illinois, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States