Master Protocol for Crizotinib Continuation Sub-Studies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Jan 2023 → ongoing

Decision date (initial)

2024-05-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2024-511128-15-00

EudraCT number

2021-006010-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To monitor safety of crizotinib
Current sub-protocol (included in this submission) A8081013 - to monitor safety of crizotinib

Secondary objectives 1

1. N/A

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by the investigator) in a Pfizer-sponsored Crizotinib Parent Study.
2. 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).
3. 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.
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 2

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. AEs leading to permanent discontinuation of crizotinib
2. All SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications