Crizotinib Continuation Clinical Study

NSCLC Clinical Trial

Official title:

CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160922
• Other study ID #: A8081075
• Status: Recruiting
• Phase: Phase 4
• Start date: December 27, 2021
• Est. completion date: December 26, 2026

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 26, 2026
• Est. primary completion date: December 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALCL
• IMT
• NSCLC

Intervention

Drug:
• crizotinib
crizotinib oral treatment

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Fujian Province Oncology Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical University.	Guang Zhou	Guangdong
China	Sun Yat-Sen University Cancer center	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer center	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer center	Guangzhou	Guandong
China	The First Affiliated Hospital of Guangzhou Medical University.	Guangzhou
China	The First Affiliated Hospital of College of Medicine,Zhejiang University	Hangzhou	Zhejiang
China	Shanghai Chest Hospital	Shanghai
China	West China Hospital of Sichuan University	Wuhou District,Chengdu	Sichuan
Italy	ASST Monza	Monza	MB
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Russian Federation	Limited Liability Company "EuroCityClinic"	Saint-Petersburg
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Italy,  Japan,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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