ALCL, IMT, NSCLC
Conditions
Keywords
crizotinib, Xalkori, Anaplastic Lymphoma Kinase, ALK, ROS1, NSCLC, Non-small Cell Lung Cancer, ALCL, anaplastic large cell lymphoma, IMT, inflammatory myofibroblastic tumour
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.
Interventions
DRUGcrizotinib
crizotinib oral treatment
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events leading to permanent discontinuation of study intervention | 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 | Baseline up to approximately 5 years | Safety data collection in this study will permit further characterization of the safety profile of crizotinib. |
Countries
China, Italy, Japan, Russia, Taiwan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed