2023-508952-21-00
Active, Not Recruiting
Phase 4
B7461039 LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALKPOSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Inc.
- Enrollment
- 17
- Locations
- 3
- Primary Endpoint
- AEs leading to permanent discontinuation of lorlatinib
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
To monitor the safety and tolerability of study intervention(s)
Investigators
Dana Kennedy
Scientific
Pfizer Inc.
Eligibility Criteria
Inclusion Criteria
- •Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
- •Participants must agree to follow the reproductive criteria as outlined in Appendix 3 (Section 10.3.1 for males and Section 10.3.2 for females).
- •Adequate organ function as defined by the following criteria: • Hepatic function: Serum AST and serum ALT ≤2.5 × 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: absolute neutrophil count ≥1000/μL (1.0 x 109 /L or 1000/mm3), platelets ≥50,000/μL (50 x 109 /L or 50000/mm3); hemoglobin ≥8.0 g/dL; • Renal function: Serum creatinine ≤2.0 × ULN.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
- •Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
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.
Outcomes
Primary Outcomes
AEs leading to permanent discontinuation of lorlatinib
AEs leading to permanent discontinuation of lorlatinib
All SAEs
All SAEs
Study Sites (3)
Loading locations...
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