Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan

  • Interventional
  • Recruiting
  • NCT04319198
Eligibility Details Visit Clinicaltrials.gov

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

Rollover study designed to evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continued treatment with sacituzumab govitecan. Patients currently receiving, clinically benefiting from, and tolerating sacituzumab govitecan in an Immunomedics-sponsored parent study planned for closure will be considered for enrollment.

This is an open-label, longitudinal cohort, rollover study. Eligible participants will receive sacituzumab govitecan therapy at the dose they were receiving in the parent study. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan. Treatment with sacituzumab govitecan will be uninterrupted as eligible participants rollover/transition from the parent study to the rollover study. Participants may continue to receive sacituzumab govitecan until they experience toxicity, disease progression, loss of clinical benefit, lost to follow-up, or upon participant withdrawal of consent or Sponsor termination of the study.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Receiving ongoing treatment with sacituzumab govitecan in an Immunomedics-sponsored study that is closing

         - Continuing to receive clinical benefit from sacituzumab govitecan therapy

        Exclusion Criteria:

         - Women who are pregnant or lactating

         - Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the Immunomedics-sponsored study in which they participated

         - Experienced a toxicity from sacituzumab govitecan 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.

At a Glance

National Government IDNCT04319198

IRB#IRB20-1063

Lead SponsorGilead Sciences

Lead PhysicianRita Nanda

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting