Clinical trial NCT04319198: Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Solid Tumor
Keywords: ADC
Antibody-Drug Conjugate
Trop-2
SN-38
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing any Adverse Events
timeFrame: First dose date up to last dose date plus 30 days (approximately 3 years)
measure: Percentage of Participants Experiencing any Serious Adverse Events
timeFrame: First dose date up to last dose date plus 30 days (approximately 3 years)
measure: Percentage of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose date up to last dose date plus 30 days (approximately 3 years)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services, Christiana Hospital
state: Delaware
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Miami
country: United States
facility: Baptist Health - Miami Cancer Institute
state: Florida
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of MD Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Port Jefferson
country: United States
facility: New York Cancer & Blood Specialists - Setauket Medical Oncology
state: New York
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Austin
country: United States
facility: Next Oncology
state: Texas
city: Houston
country: United States
facility: Oncology Consultants,P.A.
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Namur
country: Belgium
facility: CHU UCL NAMUR - Sainte Elisabeth
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.