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May 14, 2014
08:35 EDTPBYIPuma Biotechnology expands cohort in Phase II trial of PB272
Puma Biotechnology has expanded the first cohort from its Phase II clinical trial of its lead drug candidate PB272 as a single agent in patients with solid tumors who have an activating HER2 mutation. The cohort that has been expanded is the cohort that includes patients with metastatic breast cancer that is not HER2 amplified or overexpressed and has a HER2 mutation. The Phase II basket trial, which was initiated in October 2013, is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating HER2 mutations. The cohorts included in the study are: (1) bladder/urinary tract cancer; (2) colorectal cancer; (3) endometrial cancer; (4) gastric/esophageal cancer; (5) ovarian cancer; (6) EGFR mutated and/or amplified primary brain cancer; (7) solid tumors with a HER3 mutation, and (8) all other solid tumors with a HER2 mutation. The breast cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” basket and due to the preliminary activity seen in the trial the company has expanded the basket, as per the protocol for the trial. The expanded basket will initially enroll a total of 18 patients.
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