Crizotinib Continuation Clinical Study
Phase 4
- Conditions
- SCLC, ALCL, IMT
- Registration Number
- JPRN-jRCT2041210125
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
*Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
*Participants must agree to follow the reproductive criteria as outlined in protocol.
*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 below.
*Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.
Exclusion Criteria
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]<br>Safety data collection in this study will permit further characterization of the safety profile of crizotinib.<br>2.Number of serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]<br>Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
- Secondary Outcome Measures
Name Time Method