Master Protocol for Crizotinib Continuation Sub-Studies
EU CTIS ID: 2024-511128-15-00
What this study is testing
To monitor safety of crizotinib Current sub-protocol (included in this submission) A8081013 - to monitor safety of crizotinib
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Any participant who is receiving crizotinib and deriving clinical benefit (as determined by the investigator) in a Pfizer-sponsored Crizotinib Parent Study.
- Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females).
- No ongoing NCI CTCAE Grade ≥3 or intolerable Grade 2 Aes considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4.
- Adequate organ function as defined by the following criteria: Adults Participants (≥18 years): • Hepatic function: Serum AST and serum ALT ≤3 × ULN, or AST and ALT ≤5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin ≤1.5 × ULN (except participants with documented Gilbert's syndrome); • Bone marrow function: ANC ≥1000/μL, platelets ≥50,000/μL; hemoglobin ≥8.0 g/dL; • Stable renal function for at least 14 days. Pediatric Participants (<18 years): • Hepatic function defined as ≤3 × ULN for ALT and AST and ≤1.5 ×ULN for bilirubin, or ≤5 × ULN for ALT and AST and ≤1.5 × ULN for bilirubin in case of liver involvement by metastases; • Adequate hematological function: • ANC ≥750/μL and platelets ≥75,000/μL for participants without bone marrow involvement; • Participants with bone marrow involvement will be allowed to enter with ANC ≥500/μL and platelets ≥50,000/μL; • Stable renal function for at least 14 days.
You likely can't join if
- Female participants who are pregnant or breastfeeding.
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Japan
- Taiwan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Japan; Taiwan; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.