Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

NCT03672643 | Terminated Phase 4 Results

• 1 other identifier: A8081067
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 14

Brief Summary

This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

Conditions

ALK or ROS1-positive NSCLC

Keywords

NSCLC

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 3 or 4 Adverse Events (AEs), Grade 5 AEs, AEs Lead to Treatment Discontinuation, Serious AEs (SAEs)- All Causality: Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

  An AE was any untoward medical occurrence in a clinical study participant associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 4.03: Grade 3 indicates severe AE, Grade 4 indicates life-threatening consequences and urgent intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.

  From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)

• Number of Participants With Grade 3 or 4 AEs, Grade 5 AEs, AEs Leading to Treatment Discontinuation and SAEs- Treatment Related: Assessed by NCI CTCAE v4.03

  An AE was any untoward medical occurrence in a clinical study participant associated with use of study intervention, whether or not considered related to study intervention. AEs that were related to treatment were evaluated in this outcome measure. Treatment relatedness was judged by investigator. According to NCI CTCAE version 4.03: Grade 3= severe AE, Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. Participants who discontinued treatment due to treatment related AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event.

  From first dose of study treatment up to 28 days after last dose (maximum follow up approximately up to 52.3 months; maximum exposure to treatment was 51.3 months)

Study Arms (1)

single arm

OTHER

Crizotinib

Drug: Crizotinib

Interventions

Crizotinib DRUG

receive crizotinib orally

Also known as: Xalkori

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment.
• No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3
• Adequate organ function as defined by the following criteria

You may not qualify if:

• Use of any anticancer drug subsequent to crizotinib prior to study entry
• Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
• Use of drugs that are known potent CYP3A4 inducers
• Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

Fujian Province Oncology Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Liwan District,Guangzhou, Guangdong, 510145, China

Location

Eastern Theater General Hospital ,QinHuai District Medical Area

Nanjing, Jiangsu, 210002, China

Location

Jilin Province Cancer Hospital

Changchun, Jilin, 130000, China

Location

Jilin Provincial Cancer Hospital

Changchun, Jilin, 130012, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Sichuan Province Cancer Hospital/Department of Pulmonary Tumor

Chengdu, Sichuan, 610041, China

Location

Sichuan Province Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Beijing Cancer Hospital, Internal Department

Beijing, 100142, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Related Links

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

MeSH Terms

Interventions

Crizotinib

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, open label study.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: September 14, 2018
• Study Start: January 28, 2019
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (14)