Crizotinib Continuation Clinical Study

Phase 4Active Not RecruitingNCT05160922

Pfizer27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC ALCL IMT

Interventions

crizotinibDRUG

crizotinib oral treatment

Eligibility

Sex: ALLMin age: 1 YearMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (13)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Province Oncology Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

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

Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

Time frame: Baseline up to approximately 5 years

Number of serious adverse events reported for all participants

Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

Time frame: Baseline up to approximately 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.