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Crizotinib Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Crizotinib Clinical Studies (Crizotinib Continuation Clinical Study)

Crizotinib Continuation Clinical Study (Crizotinib Continuation Clinical Study)

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Not Recruiting

Dec. 27, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

*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 below.
*Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

*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.

Both

NSCLC, ALCL, IMT

Drug: crizotinib
crizotinib oral treatment
Other Name: XALKORI

1.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.
2.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.

NA

+81-52-951-1111

Dec. 09, 2021

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

China/Italy/Russia/Taiwan