EUCTR2010-022978-14-Outside-EU/EEA进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study.
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Histologically or cytologically proven diagnosis of advanced malignancy other than NSCLC for whom no standard therapy is available
- •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 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.
- •4. Any prior treatment (chemotherapy or major surgery) must have been completed at least 4 weeks prior to initiation of study medication. Any prior radiation (except palliative) or minor surgeries/procedures must have been completed at least 2 weeks prior to the initiation of study medication. Palliative radiation (=10 fractions) must have been completed 48 hrs prior to crizotinib therapy commencing. Any acute toxicity must have been recovered to = Grade 1 (except alopecia).
- •5. Female or male, 15 years of age or older. Admission of minors to the study will be as appropriate according to institutional approvals. For patients enrolled in Japan: consent from a legally acceptable representative is required for all patients who are under 20 years old.
- •6. ECOG performance status 0-3.
- •7. Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST/ALT =5 x ULN if the enzyme elevation is considered to be due to a cancer-related cause such as liver metastases
- •Patients with an ALT >5X ULN considered to be due to a cancer-related cause such as liver metastases, may enroll after discussion with the sponsor.
- •Total serum bilirubin =1.5 x ULN.
- •Absolute neutrophil count (ANC) =1000/µL (=750/µL for hematologic malignancies).
- •Platelets =30,000/µL.
- •Hemoglobin = 8.0 g/dL (= 7.0 g/dL for hematologic malignancies).
- •Serum creatinine =2.0 x ULN.
- •8. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •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 unless under treatment.
- •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.
- •8. Ongoing uncontrolled congestive heart failure.
- •9. Ongoing cardiac dysrhythmias of NCI CTCAE Grade = 2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
- •10. Known interstitial fibrosis or interstitial lung disease.
- •11. Pregnancy or breastfeeding.
- •12. Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to amprenavir, atazanavir, clarithromycin, delavirdine, diltiazem, erythromycin, indinavir, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil, voriconazole, and grapefruit or grapefruit juice.
- •13. Concurrent use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, tipranavir, ritonavir, and St. John’s wort.
- •14. Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to aripiprazole, ergotamine, halofantrine, pimozide, triazolam, astemizole*, cisapride*, and terfenadine* (* withdrawn from U.S. market).
- •15. Prior malignancy (other than current malignancy): patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or in situ cervical cancer, or prostate cancer) within the last 3 years.
- •16. Active wound healing problems such as chronic wound.
- •17. Active gastrointestinal problems or symptoms such as a gastrointestinal ulcer or Grade = 3 diarrhea.
- •18. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
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