Crizotinib Continuation Clinical Study

Phase 4

Active, not recruiting

• Conditions: IMT; NSCLC; ALCL
• Interventions: Drug: crizotinib

• Registration Number: NCT05160922
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-16
• Study Start: 2021-12-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2028-03-21
• Study Completion: 2028-03-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
crizotinib	crizotinib	crizotinib oral treatment

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events reported for all participants	Baseline up to approximately 5 years	Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Number of participants with adverse events leading to permanent discontinuation of study intervention	Baseline up to approximately 5 years	Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

Trial Locations

Locations (13)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Province Oncology Hospital; 🇨🇳 Fuzhou, Fujian, China

Sun Yat-Sen University Cancer center; 🇨🇳 Guangzhou, Guangdong, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

West China Hospital of Sichuan University; 🇨🇳 Wuhou District, Sichuan, China

The First Affiliated Hospital of College of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Guangzhou Medical University.; 🇨🇳 Guangzhou, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, China

ASST Monza; 🇮🇹 Monza, MB, Italy

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