drugset / Trial / NCT00672295

PH I SRC Kinase, Dasatinib Combo Paclitaxel & Carboplatin in Pts w Ovarian, Peritoneal, & Tubal Cancer

NCT00672295

Phase 1 Completed 11 enrolled AA Secord
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-08
Primary completion
2011-09
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Subject Paclitaxel Small molecule 150 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject dasatinib anhydrous Small molecule 50 mg Oral
Subject dasatinib anhydrous Small molecule 250 mg Oral