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

NCT01945021 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2021-02-21

Study results available
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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

Conditions

  • Non Small Cell Lung Cancer
  • ROS1 Proto Oncogene
  • Crizotinib

Interventions

DRUG

Crizotinib

Sponsors & Collaborators

  • OxOnc Development LP

    collaborator OTHER

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-07-31
Completion
2020-01-22

Countries

  • China
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945021 on ClinicalTrials.gov