Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer

Not Applicable

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-UMIN000031623
• Lead Sponsor: ational Kyushu Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-20
• Study Completion: 2021-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Patients presenting with any of the following will not be included in the trial: 1) Current treatment on another therapeutic clinical trial. 2) Characterized ALK or ROS1-positive rearrangement 3) Prior therapy specifically directed against MET 4) Any prior treatment (chemotherapy, radiation or surgery) within 2 weeks prior to study entry. 5) Any > Grade 1 acute toxicity (except alopecia). 6) Symptomatic brain metastases. 7) Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease. 8) Known interstitial fibrosis or interstitial lung disease. 9) Any of the following within the 3 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. 10) Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec. 11) Pregnancy or breastfeeding. 12) Use of drugs or foods after study enrollment that are known potent CYP3A4 inhibitors. 13) Use of drugs after study enrollment that are known potent CYP3A4 inducers. 14) Use of drugs after study enrollment that are CYP3A4 substrates with narrow therapeutic indices. 15) Any other anti-cancer drugs are prohibited. 16) Evidence of active malignancy within the last 3 years. 17) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study. 18)Patients whom investigator judges to be inappropriate as a participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified