Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280631
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2006-01-19
Brief Title:
Study of TLK199 Tablets in Myelodysplastic Syndrome MDS
Sponsor:
Telik
Organization:
Telik
Study Overview
Official Title:
Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome MDS
Detailed Description:
This Phase 1-2a study is an open label dose-ranging study of TLK199 Tablets in patients with all World Health Organization or French-American-British classification types of myelodysplastic syndrome MDS In Phase 1 the safety pharmacokinetics and hematologic response rate with TLK199 Tablets will be evaluated The Phase 1 dose-ranging stage is designed to determine the maximum tolerated dose or optimal biologic dose of TLK199 Tablets Evaluation of the pharmacokinetics of TLK199 Tablets will be conducted In Phase 1 an additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the selected Phase 2a dose In Phase 2a further safety and hematologic responses by the modified International Working Group MDS response criteria will be studied
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