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

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Exclusion Criteria

Not provided

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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
Disease control rate
Safety (reporting of adverse events according to CTCAE v4.0)
Overall survival
Duration of response

Trial Locations

Locations (25)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

St. James's University Hospital; 🇬🇧 Leeds, United Kingdom

University College Hospital; 🇬🇧 London, United Kingdom

UniversitaetsMedizin Mannheim; 🇩🇪 Mannheim, Germany

Universitaetsklinikum - Essen; 🇩🇪 Essen, Germany

Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen; 🇩🇪 Muenchen, Germany

Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Helios Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

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

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

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

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

National Cancer Institute; 🇸🇰 Bratislava, Slovakia

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Erasmus MC - Sophia kindersiekenhuis; 🇳🇱 Rotterdam, Netherlands

Nottingham University Hospitals NHS Trust - City Hospital; 🇬🇧 Nottingham, United Kingdom

Universitaetsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif, France

The Institute Of Oncology; 🇸🇮 Ljubljana, Slovenia

Oslo University Hospital - Radiumhospitalet; 🇳🇴 Oslo, Norway

Maria Sklodowska-Curie Memorial Cancer Centre; 🇵🇱 Warsaw, Poland