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Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

LAST UPDATED

April 10, 2024

Clinicaltrials.gov ID

NCT04319198

EudraCT ID

2019-004868-22

CTIS ID

2023-505336-34

OVERVIEW

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

PROTOCOL SUMMARY

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, and how safe it is in participants with metastatic cancer (cancer that has spread).

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Metastatic Solid Tumor

Gender

N/A

Date

August 2020 - October 2024

Study Type

Interventional

Study Phase

Phase 4

Product

Sacituzumab Govitecan-hiy

Eligibility Information

Inclusion

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
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Exclusion

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.
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Locations

Locations (21)
Other

University of California San Francisco

San Francisco, California, United States, 94143

Other

Rocky Mountain Cancer Center

Aurora, Colorado, United States, 80012

Other

Christiana Care Health Services, Christiana Hospital

Newark, Delaware, United States, 19718

Other

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States, 33905

Other

Baptist Health - Miami Cancer Institute

Miami, Florida, United States, 33176

Other

Illinois Cancer Specialists

Arlington Heights, Illinois, United States, 60005

Other

University of Chicago

Chicago, Illinois, United States, 60637

Other

University of MD Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Other

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Other

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Other

New York Cancer & Blood Specialists - Setauket Medical Oncology

Port Jefferson, New York, United States, 11776

Other

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15213

Other

Next Oncology

Austin, Texas, United States, 78758

Other

Oncology Consultants,P.A.

Houston, Texas, United States, 77024

Other

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Other

NEXT Oncology

San Antonio, Texas, United States, 78229

Other

Institut Jules Bordet

Bruxelles, Belgium, 1000

Other

CHU UCL NAMUR - Sainte Elisabeth

Namur, Belgium, 5000

Other

Institut Bergonie

Bordeaux Cedex, France, 33076

Other

Centre Leon Berard

Lyon, France, 69373

Other

Institut Claudius Regaud

Toulouse Cedex 9, France, 31059