Active — Not RecruitingPhase 4

Crizotinib Continuation Clinical Study

China27 participantsStarted 2021-12-27

Plain-language 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.

Who can participate

Age range0 Years

SexALL

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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 #4.
✓. Adult Participants (≥18 years): 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.

What they're measuring

Number of participants with adverse events leading to permanent discontinuation of study intervention

Timeframe: Baseline up to approximately 5 years

Number of serious adverse events reported for all participants

Timeframe: Baseline up to approximately 5 years

Trial details

NCT IDNCT05160922

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03-21

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