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
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