NCT01524926

CREATE: Cross-tumoral Phase 2 With Crizotinib

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")

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 582 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma
• Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor
• Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1
• Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma
• Locally Advanced and/or Metastatic Clear Cell Sarcoma
• Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	Crizotinib (PF-02341066)	For patients of 15yo and older, Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie; for patients younger than 15yo, 280 mg/m²/dose BID, with reductions allowed to 80% as first reduction and to 60% as second reduction respectively of the initial dose.

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-12-06
• Completion: 2022-10-30
• First posted: 2012-02-02
• Last updated: 2023-12-11

Locations

25 sites across 10 countries: Belgium, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Slovenia, United Kingdom