CREATE: Cross-tumoral Phase 2 With Crizotinib (CREATE)

December 8, 2023 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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")

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

582

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Leuven, Belgium
        • U.Z. Gasthuisberg
  • France
      • Bordeaux, France
        • Institut Bergonié
      • Dijon, France
        • Centre Georges-Francois-Leclerc
      • Lyon, France
        • Centre Léon Bérard
      • Marseille, France
        • Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone
      • Villejuif, France
        • Institut Gustave Roussy
  • Germany
      • Bad Saarow, Germany
        • Helios Klinikum Bad Saarow
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus
      • Essen, Germany
        • Universitaetsklinikum - Essen
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Mannheim, Germany
        • Universitaetsmedizin Mannheim
      • Muenchen, Germany
        • Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen
  • Italy
      • Milano, Italy
        • Fondazione Irccs Istituto Nazionale Dei Tumori
  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Centre
      • Nijmegen, Netherlands
        • Radboud University Nijmegen Medical Centre
      • Rotterdam, Netherlands
        • Erasmus MC - Sophia kindersiekenhuis
  • Norway
      • Oslo, Norway
        • Oslo University Hospital - Radiumhospitalet
  • Poland
      • Warsaw, Poland
        • Maria Sklodowska-Curie Memorial Cancer Centre
  • Slovakia
      • Bratislava, Slovakia
        • National Cancer Institute
  • Slovenia
      • Ljubljana, Slovenia
        • The Institute Of Oncology
  • United Kingdom
      • Leeds, United Kingdom
        • St. James's University Hospital
      • London, United Kingdom
        • University College Hospital
      • Manchester, United Kingdom
        • Christie NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust - City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

General inclusion criteria:

  • 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.
  • The above malignancies must be incurable by conventional surgery, radiotherapy, systemic therapy or any other means.
  • Proven presence of specific ALK and/or MET pathway alteration in tumor tissue is not mandatory for patient registration.
  • Availability of tumor material for central pathology review
  • Written informed consent
  • Measurable disease according to RECIST 1.1
  • Patients with brain metastases are eligible if treated and/or neurologically stable with no ongoing requirement for corticosteroids (off steroids for at least 2 weeks) and not taking contraindicated medications. Absence of spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
  • No carcinomatous meningitis or leptomeningeal disease.
  • Any previous systemic anticancer therapy must have been completed at least 4 weeks prior to initiation of study medication.
  • No treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug before treatment with crizotinib (whatever is the longest period).
  • No prior therapy directly targeting ALK and/or MET, no previous treatment with crizotinib.
  • Major surgery must have been completed at least 4 weeks prior to initiation of study medication.
  • Prior palliative radiotherapy must have been completed at least 24 hrs prior to initiation of study medication, and minor surgical procedures must have been completed at least two weeks prior to the initiation of study medication.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or Lansky play scale ≥ 50 for children aged 1 to 12 yo
  • Adequate hematological function: ANC ≥ 1 x 109/L, platelets ≥ 30 x 109/L and hemoglobin ≥ 8 g/dL.
  • Adequate bone marrow, renal and hepatic functions
  • All related adverse events from previous therapies must have recovered to ≤ Grade 1 (except alopecia). No persistence of adverse events from prior anti-cancer therapy deemed clinically relevant.
  • No acute or chronic severe gastrointestinal conditions such as diarrhea or ulcerations.
  • Normal cardiac function and no cerebrovascular accident including transient ischemic attack.
  • No current congestive heart failure.
  • No ongoing cardiac dysrhythmias of NCI CTCAE Grade >2.
  • No uncontrolled atrial fibrillation of any grade.
  • QTc interval <470 msec.
  • Absence of interstitial lung disease.
  • No concurrent use of drugs or foods that are known strongCYP3A4 inhibitors
  • No concurrent use of drugs that are known potent CYP3A4 inducers,within 12 days prior to first dose of crizotinib
  • No concomitant intercurrent illnesses
  • Effective contraception method (if applicable)

Disease-specific inclusion criteria for patients with anaplastic large cell lymphoma

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or advanced disease.
  • Patient must have received previous systemic chemotherapy (usually a CHOP-like multidrug combination, if not medically contraindicated, with or without monoclonal antibodies), and may not qualify for further conventional therapy with curative intent.
  • No pretreatment limitations (including autologous or allogeneic stem cell- or bone marrow transplantation), provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with inflammatory myofibroblastic tumor

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or metastatic disease.
  • No mandatory pretreatment.
  • No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with papillary renal cell carcinoma type 1

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or metastatic disease.
  • No mandatory pretreatment.
  • No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with clear cell sarcoma

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or metastatic disease.
  • No mandatory pretreatment.
  • No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with alveolar soft part sarcoma

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or metastatic disease.
  • No mandatory pretreatment.
  • No pretreatment limitations, provided all other patient selection criteria are met.

Disease-specific inclusion criteria for patients with alveolar rhabdomyosarcoma

  • Patient may have received previous systemic treatment, surgery and/or radiotherapy for localized, locally advanced or metastatic disease.
  • Patient must have received previous systemic chemotherapy (usually anthracycline-based, if not medically contraindicated), and may not qualify for further conventional therapy with curative intent.
  • No pretreatment limitations, provided all other patient selection criteria are met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crizotinib in Anaplastic large cell lymphoma
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.
Experimental: Crizotinib in Inflammatory myofibroblastic tumor
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.
Experimental: Crizotinib in Papillary renal cell carcinoma type 1
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.
Experimental: Crizotinib in Clear cell sarcoma
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.
Experimental: Crizotinib in Alveolar soft part sarcoma
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.
Experimental: Crizotinib in Alveolar rhabdomyosarcoma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

December 6, 2017

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimated)

February 2, 2012

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-90101
  • 2011-001988-52 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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