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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Crizotinib

ROS1 Proto Oncogene

Non Small Cell Lung Cancer

Treatments

Drug: Crizotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01945021

OO 12-01

Details and patient eligibility

About

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

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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