Crizotinib Continuation Clinical Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NSCLC ALCL Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Granuloma Granuloma, Plasma Cell Hemic and Lymphatic Diseases IMT Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crizotinib

Drug

crizotinib oral treatment

Other names: XALKORI

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES

Important dates

Study start: 2021
Primary completion: 2028
Study completion: 2028
First posted: Dec 16, 2021
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting