Crizotinib Continuation Clinical Study

Pfizer

Status and phase

Active, not recruiting

Phase 4

Conditions

IMT

ALCL

NSCLC

Treatments

Drug: crizotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05160922

2024-511128-15-00 (Registry Identifier)

A8081075

Details and patient eligibility

About

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.

Full description

Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.

Enrollment

27 patients

Sex

All

Ages

1 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

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.

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:

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.