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Pharmaceutical industry

Keryx Biopharmaceuticals Completes Patient Enrollment in Phase 3 Trial of KRX-0401 for Refractory Colorectal Cancer

Strategic Insights

— 1 min read

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) has completed patient enrollment in a Phase 3 registration trial of KRX-0401 (perifosine) for the treatment of refractory, advanced colorectal cancer. The trial, with over 430 randomized patients, was conducted under a Special Protocol Assessment (SPA) with the FDA and with Fast-Track Designation. The Phase 3 trial, entitled the "X-PECT" trial, is a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in patients with refractory advanced colorectal cancer.

Key Takeaways:

  • The Phase 3 trial, with over 430 patients, will evaluate the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in refractory advanced colorectal cancer patients.
  • The primary endpoint is overall survival, with secondary endpoints including overall response rate, progression-free survival, and safety.
  • Dr. Johanna Bendell and Dr. Cathy Eng are the Study Chair and Lab Correlative Study Chair, respectively, for the Phase 3 investigational team.
  • Sixty-five U.S. sites are participating in the study.
  • Perifosine is also being investigated in a Phase 3 trial for the treatment of relapsed/refractory multiple myeloma.
  • KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada, and Mexico.
  • The rapid enrollment of patients into the study, in less than 16 months, highlights the need for alternative therapies for refractory colorectal cancer patients.

Statistics:

  • Over 430 patients were randomized in the Phase 3 trial.
  • Approximately 360 events of death will trigger the un-blinding of the study.
  • The trial has 65 U.S. sites participating.
  • Perifosine has been designated as a Fast-Track and Orphan Drug candidate.

Sources:

  • Clinical Trial Research
  • Keryx Biopharmaceuticals Inc.
  • NewsRx.com
  • Clinical Trials Week via NewsRx.com
  • Special Protocol Assessment (SPA) with the FDA.

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