Crizotinib Continuation Clinical Study

NCT05160922 · tracked via the Priya Life Science Taiwan tracker

Sponsor

Pfizer

Phase

Phase 4

Started

2021-12-27

Last updated

2026-03-30

Condition(s) studied

NSCLCALCLIMT

Investigational drug(s) / intervention(s)

crizotinib →

crizotinib: crizotinib oral treatment

Study 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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

—

Healthy volunteers

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 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.

Primary outcome measure(s)

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.
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.

Trial sites (13)

Facility	City	Region
Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing Municipality
Beijing Cancer Hospital	Beijing	Beijing Municipality
Fujian Province Oncology Hospital	Fuzhou	Fujian
Sun Yat-Sen University Cancer center	Guangzhou	Guangdong
The First Affiliated Hospital of Guangzhou Medical University.	Guangzhou	Guangzhou
Jilin Cancer Hospital	Changchun	Jilin
West China Hospital of Sichuan University	Wuhou District	Sichuan
The First Affiliated Hospital of College of Medicine,Zhejiang University	Hangzhou	Zhejiang
Shanghai Chest Hospital	Shanghai	China
ASST Monza	Monza	MB
National Hospital Organization Nagoya Medical Center	Nagoya	Aichi-ken
Limited Liability Company "EuroCityClinic"	Saint Petersburg	Russia
National Taiwan University Hospital	Taipei	Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05160922 on ClinicalTrials.gov ↗ ← All trials in Taiwan