Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.
Phase of Trial: Phase II
Latest Information Update: 06 Mar 2019
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At a glance
- Drugs Dacomitinib (Primary)
- Indications Penile cancer; Squamous cell cancer
- Focus Proof of concept; Therapeutic Use
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History