Ignite Creation Date:
2024-05-05 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00672295
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2008-05-04
Brief Title:
PH I SRC Kinase Dasatinib Combo Paclitaxel Carboplatin in Pts w Ovarian Peritoneal Tubal Cancer
Sponsor:
AA Secord
Organization:
Duke University
Study Overview
Official Title:
A Phase I Trial of A SRC Kinase Inhibitor Dasatinibin Combination With Paclitaxel and Carboplatin in Patients With Advanced or Recurrent Ovarian Peritoneal and Tubal Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Primary objective to determine the maximal tolerated MTD of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment
Secondary objectives to describe the toxicity of this combination of therapy to describe the pharmacokinetics and pharmacodynamics parameters related to this combination to describe the clinical activity as defined as the response rate complete and partial response rate and progression-free survival 6 month to compare the SRC pathway microarray signature in pre and post-treatment cancer specimens to evaluate SRC pathway downstream substrates FAX paxcillin and CRK-L in pre and post-treatment cancer specimens
Secondary objectives to describe the toxicity of this combination of therapy to describe the pharmacokinetics and pharmacodynamics parameters related to this combination to describe the clinical activity as defined as the response rate complete and partial response rate and progression-free survival 6 month to compare the SRC pathway microarray signature in pre and post-treatment cancer specimens to evaluate SRC pathway downstream substrates FAX paxcillin and CRK-L in pre and post-treatment cancer specimens
Detailed Description:
This is a phase I multicenter study designed to determine the maximal tolerated dose MTD and toxicity of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment in patients with advanced or recurrent ovarian peritoneal and tubal carcinoma The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable patient experiences a dose-limiting toxicity DLT due to the combination of dasatinib paclitaxeland carboplatin during the first cycle of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9311-06-R0 | None | None | None |
| 105821b | None | None | None |