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Cell Therapeutics Says Study Achieved Endpoint Compared to Other Trials

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Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported on interim results from a cooperative group sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer that were presented at the San Antonio Breast Cancer Symposium (SABCS) held from December 4-8, 2012.

The study enrolled women with confirmed measurable metastatic disease and triple negative subtype breast cancer. At the time of data analysis, 48 women had been enrolled in the study and 47 were evaluable for efficacy. Approximately half of the patients had received between two and four prior chemotherapy regimens in the metastatic setting. The primary endpoint of the trial is 3-month progression-free survival (PFS). Secondary endpoints include overall response rate (ORR), duration of response, 6-month PFS, overall survival (OS) and safety. In this study, patients received cisplatin on Day 1, brostallicin on Day 2, and GCSF or pegylated-GCSF on Day 3, with the cycle repeated every 21 days. The study is led by principal investigator Dr. Alvaro Moreno-Aspitia, Assistant Professor of Medicine, Mayo Clinic, Jacksonville, FL. Key findings include:

Posted-In: News FDA

 

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