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NCT04319198 Clinical Trial

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

Metastatic Solid Tumor Clinical Trial

Official title:
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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04319198
Other study ID # IMMU-132-14
Secondary ID 2019-004868-2220
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date August 4, 2020
Est. completion date October 2024

Study information
Verified date June 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

This is a rollover study. Only participants who continue to receive clinical benefit from continuation of sacituzumab govitecan-hziy therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive sacituzumab govitecan-hziy at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sacituzumab Govitecan-hiy
Administered intravenously

Locations
Country Name City State
Belgium Institut Jules Bordet Bruxelles
Belgium CHU UCL NAMUR - Sainte Elisabeth Namur
France Institut Bergonie Bordeaux Cedex
France Centre Leon Berard Lyon
France Institut Claudius Regaud Toulouse Cedex 9
United States Illinois Cancer Specialists Arlington Heights Illinois
United States Rocky Mountain Cancer Center Aurora Colorado
United States Next Oncology Austin Texas
United States University of MD Greenebaum Comprehensive Cancer Center Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Florida Cancer Specialists & Research Institute Fort Myers Florida
United States Oncology Consultants,P.A. Houston Texas
United States The University of Texas M.D. Anderson Cancer Center Houston Texas
United States Baptist Health - Miami Cancer Institute Miami Florida
United States Christiana Care Health Services, Christiana Hospital Newark Delaware
United States UPMC Hillman Cancer Center Pittsburgh Pennsylvania
United States New York Cancer & Blood Specialists - Setauket Medical Oncology Port Jefferson New York
United States NEXT Oncology San Antonio Texas
United States University of California San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Experiencing any Adverse Events First dose date up to last dose date plus 30 days (approximately 3 years)
Primary Percentage of Participants Experiencing any Serious Adverse Events First dose date up to last dose date plus 30 days (approximately 3 years)
Primary Percentage of Participants Experiencing Laboratory Abnormalities The percentage of participants experiencing any clinically significant laboratory abnormality will be summarized. First dose date up to last dose date plus 30 days (approximately 3 years)
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