Clinical trial NCT05160922: Crizotinib Continuation Clinical Study
Official title: CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: NSCLC
ALCL
IMT
Keywords: crizotinib
Xalkori
Anaplastic Lymphoma Kinase
ALK
ROS1
NSCLC
Non-small Cell Lung Cancer
ALCL
anaplastic large cell lymphoma
IMT
inflammatory myofibroblastic tumour
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events leading to permanent discontinuation of study intervention
timeFrame: Baseline up to approximately 5 years
measure: Number of serious adverse events reported for all participants
timeFrame: Baseline up to approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Oncology Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer center
state: Guangdong
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Wuhou District
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine,Zhejiang University
state: Zhejiang
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Monza
country: Italy
facility: ASST Monza
state: MB
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "EuroCityClinic"
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: