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

An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and Carboplatin	Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.
DRUG	P276-00 along with Gemcitabine and carboplatin	In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2014-03-01
• First posted: 2011-04-11
• Last updated: 2014-09-04

Locations

4 sites across 1 country: United States