A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma

Trial ID: NCT04559230

Interventional - Phase 2 - Recruiting

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.

Conditions

• Recurrent Glioblastoma

Interventions

• Sacituzumab Govitecan

Eligibility

Inclusion criteria

• 1. At least 18 years of age.
• 2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.
• 3. Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma. IDH-mutant glioma is not allowed.
• 4. Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated.
• Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.
• Inclusion of additional investigational therapy with standard frontline therapy is not

Exclusion criteria

• 1. Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors
• 2. The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
• 3 The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
• 4\. The subject is unable to undergo MRI scan (eg, has pacemaker). 5. The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
• 6\. The subject is pregnant or breast-feeding. 7. The subject has serious intercurrent illness, such as:
• hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
• non-healing wound, ulcer, or bone fracture
• significant cardiac arrhythmias
• untreated hypothyroidism
• unhealed rectal or peri-rectal abscess
• uncontrolled active infection
• symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
• any history of cardiac arrhythmia or heart block
• stroke or transient ischemic attack within 6 months 8. The subject has received any of the following prior anticancer therapy:
• Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
• Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
• Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
• Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
• Prior treatment with carmustine wafers 9. Patients with radiographically or clinically apparent leptomeningeal involvement are excluded.

Sponsor

The University of Texas Health Science Center at San Antonio

Source: ClinicalTrials.gov

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