Clinical Trials in Italy / NCT05160922
Active, not recruiting
Phase 4
Crizotinib Continuation Clinical Study
NCT05160922 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
NSCLCALCLIMT
Study 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.
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.
Primary outcome measure(s)
- Number of participants with adverse events leading to permanent discontinuation of study intervention — Baseline up to approximately 5 years
Safety data collection in this study will permit further characterization of the safety profile of crizotinib. - Number of serious adverse events reported for all participants — Baseline up to approximately 5 years
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | |
| Fujian Province Oncology Hospital | Fuzhou | Fujian | |
| Sun Yat-Sen University Cancer center | Guangzhou | Guangdong | |
| The First Affiliated Hospital of Guangzhou Medical University. | Guangzhou | Guangzhou | |
| Jilin Cancer Hospital | Changchun | Jilin | |
| West China Hospital of Sichuan University | Wuhou District | Sichuan | |
| The First Affiliated Hospital of College of Medicine,Zhejiang University | Hangzhou | Zhejiang | |
| Shanghai Chest Hospital | Shanghai | China | |
| ASST Monza | Monza | MB | |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | |
| Limited Liability Company "EuroCityClinic" | Saint Petersburg | Russia | |
| National Taiwan University Hospital | Taipei | Taiwan |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05160922 on ClinicalTrials.gov ↗ ← All trials in Italy