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

April 9, 2024 updated by: Gilead Sciences

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet
      • Namur, Belgium, 5000
        • CHU UCL NAMUR - Sainte Elisabeth
  • France
      • Bordeaux Cedex, France, 33076
        • Institut Bergonie
      • Lyon, France, 69373
        • Centre Leon Berard
      • Toulouse Cedex 9, France, 31059
        • Institut Claudius Regaud
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services, Christiana Hospital
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Florida Cancer Specialists & Research Institute
      • Miami, Florida, United States, 33176
        • Baptist Health - Miami Cancer Institute
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of MD Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • Port Jefferson, New York, United States, 11776
        • New York Cancer & Blood Specialists - Setauket Medical Oncology
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Hillman Cancer Center
    • Texas
      • Austin, Texas, United States, 78758
        • NEXT Oncology
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Oncology Consultants,P.A.
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Drug: Sacituzumab Govitecan-hiy
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
  • Trodelvy™

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)
First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Serious Adverse Events
Time Frame: First dose date up to last dose date plus 30 days (approximately 3 years)
First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing Laboratory Abnormalities
Time Frame: 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.
First dose date up to last dose date plus 30 days (approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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