Crizotinib Continuation Clinical Study

NCT ID: NCT05160922

Last Updated: 2025-09-03

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-27

Study Completion Date

2028-03-21

Brief Summary

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The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.

Detailed Description

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Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.

Conditions

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NSCLC ALCL IMT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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crizotinib

crizotinib oral treatment

Group Type OTHER

crizotinib

Intervention Type DRUG

crizotinib oral treatment

Interventions

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crizotinib

crizotinib oral treatment

Intervention Type DRUG

Other Intervention Names

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XALKORI

Eligibility Criteria

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Inclusion Criteria

1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
2. Participants must agree to follow the reproductive criteria as outlined in protocol.
3. No ongoing Grade ≥3 or intolerable Grade 2 AEs considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4.
4. Adult Participants (≥18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Pediatric Participants (\<18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Exclusion Criteria

Participants with any of the following characteristics/conditions will be excluded:

1. Female participants who are pregnant or breastfeeding.
2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Minimum Eligible Age

1 Year

Maximum Eligible Age

99 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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Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Province Oncology Hospital

Fuzhou, Fujian, China

Site Status

Sun Yat-Sen University Cancer center

Guangzhou, Guangdong, China

Site Status

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

West China Hospital of Sichuan University

Wuhou District, Sichuan, China

Site Status

The First Affiliated Hospital of College of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, , China

Site Status

Shanghai Chest Hospital

Shanghai, , China

Site Status

ASST Monza

Monza, MB, Italy

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Site Status

Limited Liability Company "EuroCityClinic"

Saint Petersburg, , Russia

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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China Italy Japan Russia Taiwan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A8081075

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

Other Identifiers

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2024-511128-15-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

A8081075

Identifier Type: -

Identifier Source: org_study_id

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