Crizotinib Continuation Clinical Study
CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES
2 other identifiers
interventional
27
5 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2021
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
December 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 21, 2028
March 30, 2026
March 1, 2026
6.2 years
December 6, 2021
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events leading to permanent discontinuation of study intervention
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Baseline up to approximately 5 years
Number of serious adverse events reported for all participants
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Baseline up to approximately 5 years
Study Arms (1)
crizotinib
OTHERcrizotinib oral treatment
Interventions
Eligibility Criteria
You may qualify if:
- Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
- Participants must agree to follow the reproductive criteria as outlined in protocol.
- 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.
You may not qualify if:
- Participants with any of the following characteristics/conditions will be excluded:
- Female participants who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Province Oncology Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-Sen University Cancer center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangzhou, 510120, China
Jilin Cancer Hospital
Changchun, Jilin, 130028, China
West China Hospital of Sichuan University
Wuhou District, Sichuan, 610041, China
The First Affiliated Hospital of College of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310003, China
Shanghai Chest Hospital
Shanghai, 200030, China
ASST Monza
Monza, MB, 20900, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Limited Liability Company "EuroCityClinic"
Saint Petersburg, 197022, Russia
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2021
First Posted
December 16, 2021
Study Start
December 27, 2021
Primary Completion (Estimated)
March 21, 2028
Study Completion (Estimated)
March 21, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.