Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.

Trial Profile

Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.

Recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Sep 2017

At a glance

  • Drugs Dacomitinib (Primary)
  • Indications Penile cancer
  • Focus Proof of concept; Therapeutic Use
  • Most Recent Events

    • 16 Sep 2017 According to results published in the BJU International Journal, this study was originally planned according to Simons Optimal two-stage design with the criterion ORR from 5% to a desirable 20% and after achieving positive outcome the trial was amended by introduction of a stronger evidence criterion ORR>20% based on calculation of the Bayesian posterior probability, and a 90% threshold for such a probability was adopted as a stopping rule.
    • 16 Sep 2017 Results (n=28, cut-off date 12 Dec 2016) published in the BJU International Journal.
    • 05 Apr 2017 Results (n=28), presented at the 108th Annual Meeting of the American Association for Cancer Research.
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