Crizotinib Continuation Clinical Study

JRCT ID: jRCT2041210125

Registered date:08/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: NSCLC, ALCL, IMT
• Date of first enrollment: 27/12/2021
• Target sample size: 80
• Countries of recruitment: China,Japan,Italy,Japan,Russia,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Drug: crizotinib
crizotinib oral treatment
Other Name: XALKORI

Outcome(s)

Primary Outcome

1.Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
2.Number of serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

• Secondary Outcome: NA

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 99age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05160922