Overview

Crizotinib Continuation Clinical Study

Status:
Not yet recruiting
Trial end date:
2026-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Crizotinib
Criteria
Participants must meet the following key inclusion criteria to be eligible for enrollment
into the study:

1. Any participant who is receiving crizotinib and deriving clinical benefit (as
determined by their doctor) in a Crizotinib Study which is planned to close.

2. Participants must agree to follow the reproductive criteria as outlined in protocol.

3. 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.

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:

1. Female participants who are pregnant or breastfeeding.

2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the
participant from inclusion in the study.