FDA OKs Phase 2b Trial on SUBA-Itraconazole for Metastatic Castration-resistant Prostate Cancer

FDA OKs Phase 2b Trial on SUBA-Itraconazole for Metastatic Castration-resistant Prostate Cancer

The U.S. Food and Drug Administration (FDA) has cleared a Phase 2b clinical trial to evaluate the effects of combining SUBA-Itraconazole, an oral anti-fungal medication with anti-cancer properties, with chemotherapy for treating men with metastatic castration-resistant prostate cancer (mCRPC) who responded poorly to prior therapies.

The FDA accepted the investigational new drug (IND) application filed by Inhibitor Therapeutics and the company's design of the randomized, double-blind, placebo-controlled Phase 2b trial, called PREDICT.

PREDICT will evaluate the effectiveness and safety of SUBA-Itraconazole capsules given in combination with standard chemotherapy (docetaxel and prednisone) in men with mCRPC. Approximately 23,000 men in the U.S. are diagnosed each year with late-stage mCRPC that no longer responds to standard hormone therapy to lower the levels of male hormones, nor to chemotherapy or newer hormone therapies such as Xtandi (enzalutam
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