2023-508952-21-00招募中4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- AEs leading to permanent discontinuation of lorlatinib
研究概览
简要总结
To monitor the safety and tolerability of study intervention(s)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
AEs leading to permanent discontinuation of lorlatinib
AEs leading to permanent discontinuation of lorlatinib
All SAEs
All SAEs
次要结局
未报告次要终点
研究者
Dana Kennedy
Scientific
Pfizer Inc.
研究点 (3)
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