Crizotinib Continuation Clinical Study

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
NSCLC, ALCL, IMT

Intervention / Treatment
-----------------
* Drug: crizotinib


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: crizotinib<br>crizotinib oral treatment | Drug: crizotinib<br>* crizotinib oral treatment<br>* Other names: XALKORI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline up to approximately 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALK, crizotinib, Xalkori, Anaplastic Lymphoma Kinase, ROS1, NSCLC, Non-small Cell Lung Cancer, ALCL, anaplastic large cell lymphoma, IMT, inflammatory myofibroblastic tumour