Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT04319198
- Collaborators
- Not Provided
- Investigators
- Study Director: Trishna Goswami, MD Gilead Sciences
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