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FDAnews Drug Daily Bulletin

Blueprint Medicines Commences Phase I Trials for Two Investigational Cancer Drugs

July 20, 2015

The FDA has given Blueprint Medicines the go-ahead to begin Phase I clinical trials for its investigational BLU-285 and BLU-554 to treat gastrointestinal tract, liver and biliary duct cancers.

The BLU-285 trial will enroll 60 patients with unresectable, treatment-resistant gastrointestinal stromal tumor or other relapsed or refractory solid tumors, while the BLU-554 trial will involve 50 patients with advanced unresectable hepatocellular carcinoma and 10 patients with advanced unresectable cholangiocarcinoma.

Both trials will test the safety and tolerability of escalating doses of the drugs to establish a maximum tolerated dose or a recommended dose, and assess early signs of biological activity using disease-specific biomarkers. — Jonathon Shacat