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Safety and Efficacy of Xalkori ROS1

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03375242
Collaborator
(none)
100
Enrollment
1
Location
99.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
XALKORI ROS1+NSCLC DRUG USE INVESTIGATION
Actual Study Start Date :
Oct 25, 2017
Anticipated Primary Completion Date :
Feb 6, 2026
Anticipated Study Completion Date :
Feb 6, 2026

Arms and Interventions

Arm Intervention/Treatment
crizotinib

Drug: crizotinib
XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
Other Names:
  • XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of adverse drug reactions in this surveillance. [52 weeks]

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [12, 24, 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive
    Exclusion Criteria:
    • Patients with past history of hypersensitivity to any of the ingredients of XALKORI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer local country office Tokyo Japan

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03375242
    Other Study ID Numbers:
    • A8081051
    First Posted:
    Dec 18, 2017
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Crizotinib

    Study Results

    No Results Posted as of Sep 1, 2021