CREATE: Cross-tumoral Phase 2 With Crizotinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01524926
First received: January 24, 2012
Last updated: June 2, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]
  • Progression free survival [ Designated as safety issue: No ]
  • Disease control rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Correlative research endpoints [ Designated as safety issue: No ]

Estimated Enrollment: 582
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crizotinib in Anaplastic large cell lymphoma Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie
Experimental: Crizotinib in Inflammatory myofibroblastic tumor Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie
Experimental: Crizotinib in Papillary renal cell carcinoma type 1 Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie
Experimental: Crizotinib in Clear cell sarcoma Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie
Experimental: Crizotinib in Alveolar soft part sarcoma Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie
Experimental: Crizotinib in Alveolar rhabdomyosarcoma Drug: Crizotinib (PF-02341066)
Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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.
  • 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 potent CYP3A4 inhibitors
  • No concurrent use of drugs that are known potent CYP3A4 inducers
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524926

Contacts
Contact: Jonathan Steuve, MS +32 2 774 10 39 jonathan.steuve@eortc.be

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

No publications provided

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
Study First Received: January 24, 2012
Last Updated: June 2, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 20, 2014