Safety and Efficacy of Xalkori ROS1

NCT ID: NCT03375242

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2027-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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crizotinib

crizotinib

Intervention Type DRUG

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. "

Interventions

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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. "

Intervention Type DRUG

Other Intervention Names

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XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Tokyo

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A8081051

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT03375242

Identifier Type: REGISTRY

Identifier Source: secondary_id

A8081051

Identifier Type: -

Identifier Source: org_study_id

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