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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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3 April 2012 |
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Main ID: |
EUCTR2010-022978-14-IT |
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Date of registration:
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14/06/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PHASE 1B OPEN-LABEL STUDY OF THE SAFETY AND CLINICAL ACTIVITY OF CRIZOTINIB (PF-02341066) IN TUMORS WITH GENETIC EVENTS INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK ) GENE LOCUS - ND
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Scientific title:
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PHASE 1B OPEN-LABEL STUDY OF THE SAFETY AND CLINICAL ACTIVITY OF CRIZOTINIB (PF-02341066) IN TUMORS WITH GENETIC EVENTS INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK ) GENE LOCUS - ND |
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Date of first enrolment:
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10/02/2011 |
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Target sample size:
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40 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022978-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: esplorativo
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Histologically or cytologically proven diagnosis of malignancy other than NSCLC 2. Positive for a. Translocation or inversion event involving the ALK gene locus (eg, NPM-ALK fusion) as determined by immunohistochemistry (IHC) or any other suitable molecular tools such as FISH or RT-PCR or sequencing. Cases of ALK positive anaplastic large cell lymphoma must be positive for ALK expression by IHC. b. ALK amplification events defined as ALK/CEP2 ratio of =5 in =15% of evaluated cells by FISH or as greater than 7 copies by qPCR or aCGH. c. ALK activating point mutations determined by direct sequencing of the ALK gene locus including but not limited to G1128A, R1192P, R1275Q, D1091N, M1166R, I1171N, F1174I, F1174L, F1245C, F1245V, I1250T.ALK. 3. Patients with brain metastases are eligible if appropriately treated and neurologically stable for at least 2 weeks, and have no ongoing requirement for corticosteroids, for example, dexamethasone and are not taking any medications contraindicated in Exclusion Criteria #10-12.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients presenting with any of the following will not be included in the trial: 1. Mutations or amplification involving the cMet gene but not the ALK gene locus. 2. Current treatment on another therapeutic clinical trial. 3. Prior therapy specifically directed against ALK. 4. Prior allogeneic bone marrow transplant. 5. Clinically apparent or known carcinomatous meningitis, or leptomeningeal disease. 6. Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function. 7. Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of tumors with translocation, mutation, or amplification of the anaplastic lymphoma kinase (ALK)gene locus.
MedDRA version: 13.1
Level: LLT
Classification code 10065252
Term: Solid tumor
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: crizotinib
Product Code: PF-02341066
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: crizotinib
Current Sponsor code: PF-02341066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Product Name: crizotinib
Product Code: PF-02341066
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: crizotinib
Current Sponsor code: PF-02341066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Product Name: crizotinib
Product Code: PF-02341066
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: crizotinib
Current Sponsor code: PF-02341066
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
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Primary Outcome(s)
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Main Objective: Assess the safety of oral single-agent crizotinib administered to patients with advanced malignancy known to have an ALK genetic event and screen for efficacy in these patients.
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Secondary Objective: - To determine pharmacokinetics (PK) in this patient population using population PK (POPPK) methods and explore correlations between concentration, response and/or safety findings. - To correlate ALK genetic events (translocation, mutation/amplification) to outcome measures.
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Primary end point(s): Primary Endpoint: - Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities. - Overall response rate (ORR) based on RECIST version 1.1.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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