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Brief Title: 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
Official Title: 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
Study ID: NCT01333137
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Disney Cancer Center, Burbank, California, United States
3855 Health Sciences Drive, La Jolla, California, United States
UC Davis Cancer Center, Sacramento, California, United States
Washington University, St. Louis, Missouri, United States
Name: Dr.Debasish Tripathy
Affiliation: USC/Norris Comprehensive Cancer Center 1441 Eastlake Avenue, Rm 3440, Los Angeles, CA 90033
Role: PRINCIPAL_INVESTIGATOR