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Crizotinib Continuation Clinical Study

Active Not RecruitingPhase 4

Sponsor: Pfizer

Conditions: NSCLC, ALCL, IMT

Interventions: crizotinib

Countries: China, Italy, Japan, Russia, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 0 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (13)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangzhou, China
Changchun, Jilin, China
Wuhou District, Sichuan, China
Hangzhou, Zhejiang, China
Shanghai, China
Monza, MB, Italy
Nagoya, Aichi-ken, Japan
Saint Petersburg, Russia
Taipei, Taiwan