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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: CytRx

Current Primary Outcome: 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. [ Time Frame: Minimum 28 days ]

Original Primary Outcome: 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.

Current Secondary Outcome:

  • (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. [ Time Frame: Minimum 28 days ]
  • (2) To determine the safety profile and tolerability of tamibarotene in the indicated patient population. [ Time Frame: Up to 32 weeks ]
  • (3) To determine the pharmacokinetic (PK) profile of tamibarotene when administered in the indicated patient population. [ Time Frame: One year ]


Original Secondary Outcome:

  • (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.
  • (2) To determine the safety profile and tolerability of tamibarotene in the indicated patient population.
  • (3) To determine the pharmacokinetic (PK) profile of tamibarotene when administered in the indicated patient population.


Information By: CytRx

Dates:
Date Received: August 21, 2007
Date Started: September 2007
Date Completion:
Last Updated: February 11, 2013
Last Verified: February 2013