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

Pfizer Inc, 235 East 42nd Street, New York, NY 100170 个研究点目标入组 40 人开始时间: 2011年6月14日最近更新: 2012年4月3日

试验速览

暂无简介。

•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.

发起方