CREATE: Cross-tumoral Phase 2 With Crizotinib

Phase 2

Completed

• 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: Drug: Crizotinib (PF-02341066)

• Registration Number: NCT01524926
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-02
• Study Start: 2012-09
• Primary Completion: 2017-12-06
• Study Completion: 2022-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crizotinib in Alveolar rhabdomyosarcoma	Crizotinib (PF-02341066)	-
Crizotinib in Inflammatory myofibroblastic tumor	Crizotinib (PF-02341066)	-
Crizotinib in Anaplastic large cell lymphoma	Crizotinib (PF-02341066)	-
Crizotinib in Papillary renal cell carcinoma type 1	Crizotinib (PF-02341066)	-
Crizotinib in Clear cell sarcoma	Crizotinib (PF-02341066)	-
Crizotinib in Alveolar soft part sarcoma	Crizotinib (PF-02341066)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (25)

Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet; 🇧🇪 Brussels, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Georges-Francois-Leclerc; 🇫🇷 Dijon, France

Centre Leon Berard; 🇫🇷 Lyon, France

Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Helios Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

Universitaetsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Universitaetsklinikum - Essen; 🇩🇪 Essen, Germany

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