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Trial record 1 of 1 for:    NCT01524926
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CREATE: Cross-tumoral Phase 2 With Crizotinib (CREATE)

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ClinicalTrials.gov Identifier: NCT01524926
Recruitment Status : Active, not recruiting
First Posted : February 2, 2012
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE February 2, 2012
Last Update Posted Date August 8, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01524926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Safety (reporting of adverse events according to CTCAE v4.0)
  • Progression free survival
  • Disease control rate
  • Overall survival
  • Duration of response
  • Correlative research endpoints
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CREATE: Cross-tumoral Phase 2 With Crizotinib
Official Title  ICMJE 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")
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Crizotinib in Anaplastic large cell lymphoma
    Intervention: Drug: Crizotinib (PF-02341066)
  • Experimental: Crizotinib in Inflammatory myofibroblastic tumor
    Intervention: Drug: Crizotinib (PF-02341066)
  • Experimental: Crizotinib in Papillary renal cell carcinoma type 1
    Intervention: Drug: Crizotinib (PF-02341066)
  • Experimental: Crizotinib in Clear cell sarcoma
    Intervention: Drug: Crizotinib (PF-02341066)
  • Experimental: Crizotinib in Alveolar soft part sarcoma
    Intervention: Drug: Crizotinib (PF-02341066)
  • Experimental: Crizotinib in Alveolar rhabdomyosarcoma
    Intervention: Drug: Crizotinib (PF-02341066)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
582
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Netherlands,   Norway,   Poland,   Slovakia,   Slovenia,   United Kingdom
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01524926
Other Study ID Numbers  ICMJE EORTC-90101
2011-001988-52 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair: Patrick Schöffski, MD, MPH Universitaire Ziekenhuizen Leuven
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP