LOS ANGELES, Dec. 9, 2011 /PRNewswire/ -- Puma Biotechnology, Inc., a development stage biopharmaceutical company, announced that results from ongoing Phase II clinical trials of Puma's investigational drug PB272 (neratinib) were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium that is currently taking place in San Antonio, Texas. These presentations are further detailed below:
Safety and Efficacy of Neratinib in Combination With Capecitabine in Patients With ErbB2-positive Breast Cancer
The Phase I/II clinical trial of PB272 given in combination with the chemotherapy drug capecitabine was conducted at numerous locations in the United States, Europe and Asia. The trial was sponsored by Pfizer and the Phase I results of this trial were previously presented last year. The Phase II portion of the study, presented at this symposium, enrolled patients with confirmed ErbB2+ (HER2+) metastatic or locally advanced breast cancer, and documented disease progression following prior treatment with trastuzumab and taxane chemotherapy. Patients were administered PB272 at a dose of 240 mg per day in combination with capecitabine given at a dose of 1,500 mg/m2 (750 mg/m2 twice daily) on Days 1 to 14 of each 21-day cycle.
The results of the study showed that the combination of PB272 and capecitabine had acceptable tolerability. The most frequently observed severe adverse event in the trial was diarrhea with 26% of the patients experiencing grade 3/4 diarrhea. The diarrhea was reported to be transient and managed with antidiarrheal agents and dose modifications. The efficacy results from the trial showed that for the 61 patients in the trial who had not been previously treated with the HER2 targeted agent lapatinib, 7 (11%) patients experienced a complete response, 32 (52%) patients experienced a partial response and 5 (8%) patients experienced stable disease for greater than 6 mo
|SOURCE Puma Biotechnology, Inc.|
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