Sacituzumab Govitecan in Recurrent Glioblastoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT04559230
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan — DRUG
    Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.

Study Details

This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.

Key Dates

Start date
Jan 6, 2022
Status verified
Jul 2025
Primary completion
Feb 28, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab govitecan
    Dosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer CenterClevelandOhio44106
Mina Lobbous, MD, MSPH
[email protected]
216-445-3307
Mina Lobbous, MD (PRINCIPAL_INVESTIGATOR)
Texas Oncology AustinAustinTexas78705
Brian Valliant, MD
[email protected]
(512) 421-4100
Brian Valliant, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research CenterSan AntonioTexas78229
William Kelly, MD
[email protected]
210-450-1000
Epp Goodwin
[email protected]
William Kelly, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Cleveland Clinic Taussig Cancer Center· Cleveland, OHTexas Oncology Austin· Austin, TXUniversity of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center· San Antonio, TX

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