2023-505336-34-00已完成4 期
Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- The primary endpoints are as follows: Percentage of participants experiencing any AE.
研究概览
简要总结
Evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continuation of therapy with sacituzumab govitecan
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all the following inclusion criteria at Screening/Day -1 of treatment will be eligible for participation in the study.
- •Female or male subjects, ≥18 years of age, able to understand and give written informed consent
- •Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study
- •Continuing to receive clinical benefit from sacituzumab govitecan therapy
- •Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
排除标准
- •Subjects meeting any of the following exclusion criteria at Screening/Day -1 of treatment will not be enrolled in the study.
- •Women who are pregnant or lactating (Appendix 5)
- •Initiated therapy with another cancer therapeutic agent (investigational or standard of care) since receiving the last dose of the study drug on the parent study in which they participated
- •Experienced a toxicity from sacituzumab govitecan that resulted in permanent discontinuation of therapy
- •Have an active serious infection requiring IV antibiotics (Contact medical monitor for clarification)
- •Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
结局指标
主要结局
The primary endpoints are as follows: Percentage of participants experiencing any AE.
The primary endpoints are as follows: Percentage of participants experiencing any AE.
Percentage of participants experiencing any SAE.
Percentage of participants experiencing any SAE.
Percentage of participants experiencing any laboratory abnormality.
Percentage of participants experiencing any laboratory abnormality.
次要结局
未报告次要终点
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (7)
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