drugset / Trial / NCT01333137
A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
RandomizedParallel-groupOpen-labelTreatment
Summary
P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.
Timeline
- Start
- 2011-08
- Primary completion
- 2012-07
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P276-00 | Small molecule | 100 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 2 unknown | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |