Lorlatinib Continuation Study
- Registration Number
- NCT05144997
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 74
1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lorlatinib Lorlatinib Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
- Primary Outcome Measures
Name Time Method Number of participants with adverse events leading to permanent discontinuation of study intervention Baseline up to approximately 5 years Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Number of serious adverse events reported for all participants Baseline up to approximately 5 years Safety collection in this study will permit further characterization of the safety profile of lorlatinib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
UC Irvine Health
๐บ๐ธOrange, California, United States
The First affiliated Hospital of Anhui Medical University
๐จ๐ณHefei, Anhui, China
Beijing Chest Hospital, Capital Medical University
๐จ๐ณBeijing, Beijing, China
Healthcare Global Enterprises
๐ฎ๐ณBengaluru, Karnataka, India
Bhakti Vedanta Hospital & Research Institute
๐ฎ๐ณThane/Mumbai, Maharashtra, India
Guangdong Provincial People's Hospital
๐จ๐ณGuangzhou, Guangdong, China
Beijing Cancer Hospital
๐จ๐ณBeijing, Beijing, China
General Hospital of Eastern Theater Command
๐จ๐ณNanjing, Jiangsu, China
Hunan Cancer Hospital
๐จ๐ณChangsha, Hunan, China
The first hospital of jilin university
๐จ๐ณChangchun City, Jilin, China
Jilin Cancer Hospital
๐จ๐ณChangchun, Jilin, China
Sir Run Shaw Hospital
๐จ๐ณHangzhou, Qiantang District, China
Shanghai Chest Hospital
๐จ๐ณShanghai, Shanghai, China
The Second Affiliated Hospital of PLA Air Force Medical University
๐จ๐ณXi'an City, Shaanxi, China
Sichuan Cancer Hospital
๐จ๐ณChengdu, Sichuan, China
Sichuan Cancer hospital
๐จ๐ณChengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School of Medicine
๐จ๐ณHangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
๐จ๐ณHangzhou, Zhejiang, China
Zhejiang Cancer Hospital
๐จ๐ณHangzhou, Zhejiang, China
University Cancer Hospital
๐จ๐ณBeijing, China
Fudan University Shanghai Cancer Center
๐จ๐ณShanghai, China
CHU de Rennes - Hรดpital Pontchaillou
๐ซ๐ทRennes, France
Hospital Universitari Vall d'Hebron
๐ช๐ธBarcelona, Spain
Aichi Cancer Center Hospital
๐ฏ๐ตNagoya, Aichi, Japan
National University Hospital
๐ธ๐ฌSingapore, Singapore
National Cancer Centre Singapore
๐ธ๐ฌSingapore, Singapore
Hospital Vall DยดHebron
๐ช๐ธBarcelona, Cataluรฑa, Spain
National Taiwan University Hospital
๐จ๐ณTaipei, Taiwan
Institut Gustave Roussy
๐ซ๐ทVillejuif Cedex, France
Fujian Cancer Hospital
๐จ๐ณFuzhou, Fujian, China