Overview

This trial is active, not recruiting.

Conditions non small cell lung cancer, ros1 proto oncogene, crizotinib
Treatment crizotinib
Phase phase 2
Targets ALK, c-MET, ROS1
Sponsor OxOnc Development LP
Collaborator Pfizer
Start date September 2013
End date July 2015
Trial size 129 participants
Trial identifier NCT01945021, OO 12-01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
crizotinib Xalkori

Primary Outcomes

Measure
Independent Radiology Reviewed Overall Objective Response (ORR)
time frame: Starting from the first dose study treatment until the first documented CR or PR.

Secondary Outcomes

Measure
Duration of Response by Independent Review
time frame: Every 8 or 12 weeks until 6 months after the last patient was enrolled in the trial
Time to First Response
time frame: From date of first dose of crizotinib every 8 weeks or 12 weeks until first documentation of objective response is observed, until 6 months after the last subject is enrolled on the trial
Disease Control Rate at 8 Weeks by Independent Radiology Review
time frame: Measured once at 8 weeks after the start of study treatment
Progression Free Survival Assessed by Independent Radiology Review
time frame: From the date of first dose of crizotinib every 8 weeks or 12 weeks until the first documentation of objective disease progression or death
Overall Survival
time frame: Assessed from date of date of the first dose of crizotinib until the date of death from any cause, assessed up to 6 months after the last subject is enrolled on the trial
Type, Incidence, Severity, Seriousness and Relationship to Study Medications of Adverse Events (AE) and Any Laboratory Abnormalities
time frame: From the date of signed informed consent, then a minimum of every 4 weeks until 32 weeks, then a minimum of every 8 weeks, or until 4 weeks after last dose of treatment
Number of Patients With a Shift in Hematology Laboratory Results From Grade </=2 to Grade 3 or Grade 4
time frame: From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment
Number of Patients With a Shift of Chemistry Laboratory Results From Grade </= 2 to Grade 3 or Grade 4
time frame: From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment
Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30)
time frame: From the date of informed consent every 8 weeks or 12 weeks until cycle 8
Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13
time frame: From the date of informed consent every 8 weeks or 12 weeks until cycle 8

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by OxOnc Development LP.