Master Protocol for Crizotinib Continuation Sub-Studies

Phase 1

Recruiting

• Conditions: This Master Protocol for Crizotinib Continuation Sub-Studies has been designed to provide continued treatment access for eligible participants who continue to derive clinical benefit from study intervention in a Pfizer sponsored crizotinib parent study that will be closed; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511128-15-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Any participant who is receiving crizotinib and deriving clinical benefit (as determined by the investigator) in a Pfizer-sponsored Crizotinib Parent Study., Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females)., No ongoing NCI CTCAE Grade =3 or intolerable Grade 2 Aes considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4., Adequate organ function as defined by the following criteria: Adults Participants (=18 years): • Hepatic function: Serum AST and serum ALT =3 × ULN, or AST and ALT =5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin =1.5 × ULN (except participants with documented Gilbert's syndrome); • Bone marrow function: ANC =1000/µL, platelets =50,000/µL; hemoglobin =8.0 g/dL; • Stable renal function for at least 14 days. Pediatric Participants (<18 years): • Hepatic function defined as =3 × ULN for ALT and AST and =1.5 ×ULN for bilirubin, or =5 × ULN for ALT and AST and =1.5 × ULN for bilirubin in case of liver involvement by metastases; • Adequate hematological function: • ANC =750/µL and platelets =75,000/µL for participants without bone marrow involvement; • Participants with bone marrow involvement will be allowed to enter with ANC =500/µL and platelets =50,000/µL; • Stable renal function for at least 14 days.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified