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 (enzalutamide), Zytiga (abiraterone), or Erleada (apalutamide). PREDICT will determine SUBA-Itraconazole's potential to treat these patients whose disease has progressed or who have stopped other therapies due to toxicity or other reasons. The trial's primary efficacy measure will be improvements in patients' progression-free survival — the length of time until disease progression, assessed on radiography scans, or death. The study will be conducted across six countries in North America and Europe. "I am pleased to announce that we have received IND clearance for our PREDICT trial," Nicholas J. Virca, Inhibitor's president and CEO, said in press release. "FDA ... indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support an eventual New Drug Applicati
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