- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319198
Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bruxelles, Belgium, 1000
- Institut Jules Bordet
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Namur, Belgium, 5000
- CHU UCL NAMUR - Sainte Elisabeth
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Bordeaux Cedex, France, 33076
- Institut Bergonie
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Lyon, France, 69373
- Centre Leon Berard
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Toulouse Cedex 9, France, 31059
- Institut Claudius Regaud
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California
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San Francisco, California, United States, 94143
- University of California San Francisco
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Center
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Care Health Services, Christiana Hospital
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Florida
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Fort Myers, Florida, United States, 33905
- Florida Cancer Specialists & Research Institute
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Miami, Florida, United States, 33176
- Baptist Health - Miami Cancer Institute
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Illinois Cancer Specialists
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Chicago, Illinois, United States, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, United States, 21201
- University of MD Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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New York
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Port Jefferson, New York, United States, 11776
- New York Cancer & Blood Specialists - Setauket Medical Oncology
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Hillman Cancer Center
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Texas
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Austin, Texas, United States, 78758
- NEXT Oncology
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Houston, Texas, United States, 77030
- The University of Texas M.D. Anderson Cancer Center
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Houston, Texas, United States, 77024
- Oncology Consultants,P.A.
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San Antonio, Texas, United States, 78229
- NEXT Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sacituzumab Govitecan-hziy
Participants will receive sacituzumab govitecan-hziy at the dose that they were receiving in the parent study until they experience toxicity, disease progression, loss of clinical benefit, withdrawal of consent, lost to follow-up, or Sponsor termination of the study is documented. Participants who continued to receive sacituzumab govitecan-hziy in the Gilead sponsored parent study after disease progression (PD), may continue to receive sacituzumab govitecan-hziy until there is no clinical benefit as determined by the treating physician. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan-hziy. |
Administered intravenously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Experiencing any Adverse Events
Time Frame: First dose date up to last dose date plus 30 days (approximately 3 years)
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First dose date up to last dose date plus 30 days (approximately 3 years)
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Percentage of Participants Experiencing any Serious Adverse Events
Time Frame: First dose date up to last dose date plus 30 days (approximately 3 years)
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First dose date up to last dose date plus 30 days (approximately 3 years)
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Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame: First dose date up to last dose date plus 30 days (approximately 3 years)
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The percentage of participants experiencing any clinically significant laboratory abnormality will be summarized.
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First dose date up to last dose date plus 30 days (approximately 3 years)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMMU-132-14
- 2019-004868-22 (EudraCT Number)
- 2023-505336-34 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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