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A multi-center, randomized, double-blind, placebo-controlled phase IIb clinical study of SUBA-Itraconazole in combination with docetaxel and prednisone for the treatment of the metastatic castrate-resistant prostate cancer (mCRPC)

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Trial Profile

A multi-center, randomized, double-blind, placebo-controlled phase IIb clinical study of SUBA-Itraconazole in combination with docetaxel and prednisone for the treatment of the metastatic castrate-resistant prostate cancer (mCRPC)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 27 Jan 2020

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At a glance

  • Drugs Docetaxel (Primary) ; Itraconazole (Primary) ; Prednisone (Primary)
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PREDICT

Most Recent Events

  • 22 Jan 2020 According to an INHIBITOR Therapeutics media release, FDA confirmed that company can follow the 505(b)(2) pathway and, assuming positive results demonstrating an improvement in rPFS as primary endpoint, also indicated that the general design and planned analysis of the study would adequately address the objectives to support NDA submission. FDA also indicated that the final analysis of the OS an occur following submission of the NDA.
  • 22 Jan 2020 According to an INHIBITOR Therapeutics media release, this trial is expected to be carried out across approximately 35 sites in six countries in North America, Western Europe and Eastern Europe.
  • 22 Jan 2020 According to an INHIBITOR Therapeutics media release, company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate this study.

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