NCT03995706

Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0

A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan	All 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment

Timeline

• Start date: 2019-07-17
• Primary completion: 2022-06-03
• Completion: 2024-03-20
• First posted: 2019-06-24
• Last updated: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study