Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
NCT03672643
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. 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.
2. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
4. Adequate organ function as defined by the following criteria
1. Use of any anticancer drug subsequent to crizotinib prior to study entry
2. Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors
3. Use of drugs that are known potent CYP3A4 inducers
4. Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices,
associated with life threatening arrhythmias
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Nanjing, Jiangsu
- Fuzhou, Fujian
- Guangzhou, Guangdong
- Changchun, Jilin
- Shanghai, Shanghai
- Shanghai, Shanghai
- Chengdu, Sichuan
- Chengdu, Sichuan
- Hangzhou, Zhejiang
- Beijing,
- Shanghai,
Descriptive Information | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Long Term Safety Observation of Crizotinib in Chinese NSCLC Population | ||||||||||||||
Official Title ICMJE | AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED) | ||||||||||||||
Brief Summary | This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China. | ||||||||||||||
Detailed Description | This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data. | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: single arm, open label study. Masking: None (Open Label)Primary Purpose: Treatment | ||||||||||||||
Condition ICMJE | ALK or ROS1-positive NSCLC | ||||||||||||||
Intervention ICMJE | Drug: Crizotinib
receive crizotinib orally Other Name: Xalkori | ||||||||||||||
Study Arms ICMJE | single arm
Crizotinib Intervention: Drug: Crizotinib | ||||||||||||||
Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||
Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE | 75 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | December 30, 2026 | ||||||||||||||
Estimated Primary Completion Date | December 30, 2026 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||||||||
Sex/Gender ICMJE |
| ||||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
| ||||||||||||||
Listed Location Countries ICMJE | China | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03672643 | ||||||||||||||
Other Study ID Numbers ICMJE | A8081067 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
| ||||||||||||||
IPD Sharing Statement ICMJE |
| ||||||||||||||
Responsible Party | Pfizer | ||||||||||||||
Study Sponsor ICMJE | Pfizer | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
| ||||||||||||||
PRS Account | Pfizer | ||||||||||||||
Verification Date | October 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |