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Study of Sacituzumab Govitecan’s Long-Term Safety in Subjects with Metastatic Solid Tumors
EU CTIS ID: 2023-505336-34-00
What this study is testing
Evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continuation of therapy with sacituzumab govitecan
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.