CRIZOTINIB for Solid tumor

Inclusion criteria

• {"criterion_text":"- Any participant who is receiving crizotinib and deriving clinical benefit (as determined by the investigator) in a Pfizer-sponsored Crizotinib Parent Study.\n- 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).\n- 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.\n- 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

• {"criterion_text":"- Female participants who are pregnant or breastfeeding.\n- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study."}

Primary endpoints

• {"endpoint_text":"- AEs leading to permanent discontinuation of crizotinib\n- All SAEs","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

27-03-2024

Latest Decision Or Authorization Date

24-05-2024

Processing Time Days

58

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health IVH UK Limited

Responsibilities

sponsorDuties codes: 12, 2; contact sarah.wiles@syneoshealth.com

Third parties

• {"country":"United Kingdom","full_name":"Syneos Health IVH UK Limited","duties_or_roles":"sponsorDuties codes: 12, 2","organisation_type":"Pharmaceutical company"}