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
- Conditions
- Treatment of tumors with translocation, mutation, or amplification of the anaplastic lymphoma kinase (ALK)gene locus.MedDRA version: 13.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-022978-14-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method