Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
- Conditions
- Metastatic Solid Tumor
- Interventions
- Drug: Sacituzumab Govitecan-hiy
- Registration Number
- NCT04319198
- Lead Sponsor
- Gilead Sciences
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sacituzumab Govitecan-hziy Sacituzumab Govitecan-hiy 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing any Serious Adverse Events First dose date up to last dose date plus 30 days (approximately 3 years) Percentage of Participants Experiencing any Adverse Events First dose date up to last dose date plus 30 days (approximately 3 years) Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to last dose date plus 30 days (approximately 3 years) The percentage of participants experiencing any clinically significant laboratory abnormality will be summarized.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
University of California San Francisco
🇺🇸San Francisco, California, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Baptist Health - Miami Cancer Institute
🇺🇸Miami, Florida, United States
Christiana Care Health Services, Christiana Hospital
🇺🇸Newark, Delaware, United States
Oncology Consultants,P.A.
🇺🇸Houston, Texas, United States
Institut Claudius Regaud
🇫🇷Toulouse Cedex 9, France
Rocky Mountain Cancer Center
🇺🇸Aurora, Colorado, United States
Florida Cancer Specialists & Research Institute
🇺🇸Fort Myers, Florida, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
University of MD Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New York Cancer & Blood Specialists - Setauket Medical Oncology
🇺🇸Port Jefferson, New York, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
Institut Bergonie
🇫🇷Bordeaux Cedex, France
CHU UCL NAMUR - Sainte Elisabeth
🇧🇪Namur, Belgium
Centre Leon Berard
🇫🇷Lyon, France
Next Oncology
🇺🇸Austin, Texas, United States