Clinical Trial: CREATE: Cross-tumoral Phase 2 With Crizotinib

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")

Brief Summary: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

Detailed Summary:
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Antitumor activity of crizotinib

To study the antitumor activity of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or MET


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety (reporting of adverse events according to CTCAE v4.0)
  • Progression free survival
  • Disease control rate
  • Overall survival
  • Duration of response
  • Correlative research endpoints


Original Secondary Outcome: Same as current

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: January 24, 2012
Date Started: September 2012
Date Completion: December 2017
Last Updated: July 6, 2016
Last Verified: July 2016