NCT00520208

Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients Who Have Received Prior Therapy With ATRA and Arsenic Trioxide (STAR-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: CytRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Promyelocytic Leukemia

Interventions

Type	Name	Description
DRUG	Tamibarotene	For induction therapy, tamibarotene will be self-administered via tablets on an outpatient basis at a dose of 6 mg/m2 per day, taken orally, in two divided doses approximately one hour after breakfast and dinner. Induction therapy will continue for a maximum of 56 days until either a morphologic leukemia-free state or complete response (CR) has been achieved. For patients who achieve a CR with induction therapy, consolidation therapy will commence 4 to 8 weeks after the end of induction therapy. For patients who have a morphologic leukemia-free state after induction therapy but who fail to achieve a CR, consolidation therapy will commence 8 weeks after the end of induction therapy.

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2007-08-23
• Last updated: 2013-02-13

Locations

2 sites across 1 country: United States