PHASE 2, OPEN-LABEL SINGLE ARM STUDY OF THE EFFICACY AND SAFETY OF PF-02341066 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS - ND

• Conditions: treatment of locally advanced or metastatic non-small cell lung cancer after failure of one prior chemotherapy regimen in patients with tumors harboring a translocation or inversion event involving the ALK gene locus.; MedDRA version: 12.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2009-012504-13-IT
• Lead Sponsor: Pfizer Inc 235 East 42nd Street, New York, NY10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-23
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic 2. Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as determined by an ALK break apart FISH assay and defined by an increase in the distance of 5 and 3 ALK probes or the loss of the 5 probe 3. Meets one of the following criteria: - Randomized to Arm B (pemetrexed or docetaxel) of Study A8081007 and was discontinued from treatment due to RECIST version 1.1-defined progression of disease as determined by independent radiology review - Ineligibility for A8081007 due to (1) prior treatment for advanced disease with more than one chemotherapy regimen, (2) prior treatment with only one chemotherapy regimen for advanced disease and that regimen was not platinum-based, (3) prior treatment with pemetrexed as part of their platinum-based chemotherapy and did not meet the docetaxel eligibility requirements from Protocol A8081007 or (4) treated with docetaxel as part of their platinum-based prior chemotherapy but have NSCLC that is predominantly squamous cell carcinoma and thus, not eligible to be dosed with pemetrexed. 4. Patients with brain metastases are eligible if appropriately treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria #11-13 5. Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to initiation of study medication. Any acute toxicity must have been recovered to ≤ Grade 1 (except alopecia) 6. Tumors must have measurable disease as per RECIST (version 1.1); see Appendix 6 7. Female or male, 18 years of age or older 8. ECOG performance status 0-2 9. Adequate organ function as defined by the following criteria - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) /=1500/uL - Platelets >/=100,000/uL - Hemoglobin >/=9.0 g/dL - Serum creatinine Are the trial subjects under 18? no
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

1. Eligibility for Protocol A8081007 2. No prior chemotherapy for advanced NSCLC, or erlotinib or gefitinib as the only prior treatment for advanced NSCLC 3. Current treatment on another therapeutic clinical trial 4. Prior therapy specifically directed against ALK 5. Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease 6. Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack 7. Ongoing cardiac dysrhythmias of NCI CTCAE Grade >/=2, atrial fibrillation of any grade, or QTc interval >470 msec 8. Previous treatment with PF-02341066 9. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy) 10. Pregnancy or breastfeeding. 11. 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 12. 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. 13. 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) 14. Prior malignancy (other than current NSCLC): patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with PSA < ULN) within the last 5 years 15. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified