Ignite Creation Date:
2024-05-05 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00520208
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2007-08-21
Brief Title:
Safety Efficacy Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL
Sponsor:
CytRx
Organization:
CytRx
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None