Status:
COMPLETED
Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
Lead Sponsor:
Gilead Sciences
Conditions:
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).
Detailed Description
This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. P...
Eligibility Criteria
Inclusion
- Key
- Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study.
- Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.
- Key
Exclusion
- Females who are pregnant or lactating.
- Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated.
- Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04319198
Start Date
August 4 2020
End Date
October 18 2024
Last Update
September 30 2025
Active Locations (21)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Rocky Mountain Cancer Center
Aurora, Colorado, United States, 80012
3
Christiana Care Health Services, Christiana Hospital
Newark, Delaware, United States, 19718
4
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States, 33905