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Old 12-08-2016, 12:53 PM   #1
Debbie L.
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Join Date: Jul 2006
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Update to Tucatinib/ONT380 phase 2 trial

SAN ANTONIO, Texas, Dec. 07, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that following a recent meeting with the U.S. Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration. This decision is supported by the most recent data from the Company's ongoing Phase 1b study evaluating the same "triplet combination" therapy being investigated in the amended Phase 2 trial, which is tucatinib in combination with capecitabine and trastuzumab for patients with metastatic or locally advanced HER2-positive breast cancer, including patients with and without brain metastases. Tucatinib is an oral, small molecule kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR.

http://ir.cascadianrx.com/releasedet...easeID=1003085

And a poster from SABCS: http://www.cascadianrx.com/pdfs/ESMO/TiPposter2016.pdf
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