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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524926
First Posted: February 2, 2012
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  Purpose
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.

Condition Intervention Phase
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 Drug: Crizotinib (PF-02341066) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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")

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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

Estimated Enrollment: 582
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524926


Locations
Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
France
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
Germany
Helios Klinikum Bad Saarow
Bad Saarow-Pieskow, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Universitaetsklinikum - Essen
Essen, Germany
Medizinische Hochschule Hannover
Hannover, Germany
UniversitaetsMedizin Mannheim
Mannheim, Germany
Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen
Muenchen, Germany
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy
Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Erasmus MC - Sophia kindersiekenhuis
Rotterdam, Netherlands
Norway
Oslo University Hospital - Radiumhospitalet
Oslo, Norway
Poland
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland
Slovakia
National Cancer Institute
Bratislava, Slovakia
Slovenia
The Institute Of Oncology
Ljubljana, Slovenia
United Kingdom
St. James's University Hospital
Leeds, United Kingdom
University College Hospital
London, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Pfizer
Investigators
Study Chair: Patrick Schöffski, MD, MPH Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01524926     History of Changes
Other Study ID Numbers: EORTC-90101
2011-001988-52 ( EudraCT Number )
First Submitted: January 24, 2012
First Posted: February 2, 2012
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Phase 2
Crizotinib
Anaplastic large cell lymphoma
Inflammatory myofibroblastic tumor
Papillary renal cell carcinoma type 1
Alveolar soft part sarcoma
Clear cell sarcoma
Alveolar rhabdomyosarcoma

Additional relevant MeSH terms:
Sarcoma
Carcinoma, Renal Cell
Rhabdomyosarcoma
Lymphoma, Large-Cell, Anaplastic
Sarcoma, Alveolar Soft Part
Sarcoma, Clear Cell
Rhabdomyosarcoma, Alveolar
Granuloma, Plasma Cell
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective Tissue