Glioblastoma Clinical Trial
Official title:
An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification. - Completed external beam radiation therapy per standard of care. - Must have received at least 80% of planned daily doses of TMZ during chemoradiation. - Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing. - Willing to abstain from intercourse or use acceptable contraceptive methods. - If taking corticosteroids, must be on a stable or decreasing dose. Exclusion Criteria: - Recent history of recurrent or metastatic cancer that could confound response assessments - Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation therapy. - Prior Optune treatment. - Active infection or serious intercurrent medical illness. - Poorly controlled seizures. - Significant cardiac disease within 6 months of enrollment. - Poorly controlled diabetes. - Use of another investigational agent within 30 days of enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | The Cleveland Clinic | Cleveland | Ohio |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | UT MD Anderson Cancer Center | Houston | Texas |
United States | Columbia University Medical Center - Herbert Irving Pavilion | New York | New York |
United States | Lifespan Cancer Institute/Rhode Island Hospital | Providence | Rhode Island |
United States | University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Orbus Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Dose Limiting Toxicities | Protocol Defined Dose Limiting Toxicities | 8 weeks | |
Primary | Incidence of TEAEs All Grades | All Grades | 52 weeks | |
Primary | Incidence of TEAEs Grade 3+ | Grade 3+ | 52 weeks | |
Primary | Incidence of TEAEs Serious | Serious | 52 weeks | |
Primary | Incidence of TEAEs Leading to Discontinuation | Leading to Discontinuation | 48 weeks | |
Primary | Vital Signs (Heart and Respiratory Rate) | Change from Baseline in Heart Rate and Respiratory Rate | 52 weeks | |
Primary | Vital Signs (Blood Pressure) | Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | 52 weeks | |
Primary | Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests | Lab abnormalities by CTCAE v5.0 Grade | 52 weeks | |
Secondary | Progression Free Survival | Per RANO Criteria as assessed by MRI | 52 weeks | |
Secondary | Overall Response Rate | Per RANO Criteria as assessed by MRI | 52 weeks | |
Secondary | Pharmacokinetics Cmax | observed maximum concentration | Baseline to Steady State (2 weeks) | |
Secondary | Pharmacokinetics Cmin | observed minimum concentration | Baseline to Steady State (2 weeks) | |
Secondary | Pharmacokinetics Tmax | time of observed maximum concentration | Baseline to Steady State (2 weeks) | |
Secondary | Pharmacokinetics AUCt | area under the concentration-time curve | Baseline to Steady State (2 weeks) | |
Secondary | Pharmacokinetics lambdaz | elimination rate constant | Baseline to Steady State (2 weeks) | |
Secondary | Pharmacokinetics t 1/2 | elimination half life | Baseline to Steady State (2 weeks) | |
Secondary | QTcF-Concentration Relationship | Assessment of change in QTcF relative to plasma concentration of eflornithine | Baseline to Steady State (2 weeks) | |
Secondary | Assessment of QTcF | Change from baseline in QTcF | Baseline to Steady State (2 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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