CREATE (EORTC 90101)

• Research type

  Research Study

• Full title

  Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET.

• IRAS ID

  108771

• Contact name

  Sandra Strauss

• Sponsor organisation

  EORTC

• Eudract number

  2011-001988-52

• Clinicaltrials.gov Identifier

  NCT01524926

• Research summary

  This is a biomarker-driven multi-tumour single agent Phase II trial. The purpose of the trial is to test the safety and effectiveness of a new investigational drug called crizotinib in patients with 6 rare tumour types; anaplastic large cell lymphoma, inflammatory myofibroblastic tumour, papillary renal cell carcinoma type 1, alveolar soft part sarcoma, clear cell sarcoma and alveolar rhabdomyosarcoma. Significant proportions of patients with these tumour types are known to carry molecular alterations that activate genes called ‘ALK’ or ‘MET’ and early patient data suggest that crizotinib is able to keep the cancer from growing in patients with tumours that have these changes. Those alterations however are not present in all cases of these tumours type, and therefore another important objective of the trial is to analyse the molecular alterations present in patients' tumours to see if the presence of ALK/MET genes can predict response to this treatment. To be eligible for the trial patients must tumour samples available to confirm the diagnosis and to test the ALK/MET status of their tumour, but they do not have to have proven evidence of ALK/Met alterations to be registered into the trial. If patients meet all the eligibility criteria, they will receive crizotinib tablets twice a day every day as long as tolerate it or until there is progression of their disease.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  13/LO/0004

• Date of REC Opinion

  27 Feb 2013

• REC opinion

  Further Information Favourable Opinion