Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

Summary

To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OxOnc Development LP; Pfizer
• Collaborators: OxOnc Development LP; Pfizer
• Treatments: Crizotinib

Criteria

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic

• treatment-naïve or have received no more than 3 systemic treatment regimen(s)

• Positive for translocation or inversion events involving the ROS1 gene

• Negative for translocation or inversion events involving the ALK gene

• Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications

• Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication

• At least 1 measurable tumor lesion as per RECIST v1.1

• Female or male, 18 years of age or older

• ECOG performance status 0 to 1

• Adequate organ function

• Signed and dated informed consent

• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures

• Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Exclusion Criteria:

• Current treatment on another therapeutic clinical trial

• Prior therapy specifically directed against ALK or ROS1 fusion genes

• Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease

• known interstitial fibrosis or interstitial lung disease

• myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment

• Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec

• Pregnant or breast feeding

• Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers

• Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list

• Evidence of active malignancy within last 3 years