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NCT07831187

Entacapone Plus Bevacizumab for Glioblastoma at First Recurrence

StatusNot Yet Recruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Number of Participants With Dose-Limiting Toxicities
Timeframe: From the first dose through Day 28
Progression-Free Survival Assessed by Blinded Independent Central Review
Timeframe: From randomization until disease progression or death from any cause, assessed up to 30 months

Secondary (15)

Overall Survival
Progression-Free Survival Rate at 6 Months Assessed by Blinded Independent Central Review
Objective Response Rate Assessed by Blinded Independent Central Review
Duration of Response Assessed by Blinded Independent Central Review
Investigator-Assessed Progression-Free Survival
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Change From Baseline in Karnofsky Performance Status
Change From Baseline in Neurologic Assessment in Neuro-Oncology Scale Score
Change From Baseline in EORTC QLQ-C30 Scores
Change From Baseline in Dexamethasone-Equivalent Daily Corticosteroid Dose
Adherence to Oral Study Treatment
Duration of Exposure to Oral Study Treatment
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants With Serious Adverse Events
Number of Participants With Adverse Events of Special Interest
Number of Participants With Clinically Significant Liver Test Abnormalities

Arms and interventions

Open-Label Safety Lead-inExperimental

Participants in Stage 1 receive open-label entacapone 400 mg orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. Six participants evaluable for dose-limiting toxicity are enrolled in two sequential cohorts of three. Up to three participants who cannot complete the 28-day dose-limiting toxicity evaluation for reasons unrelated to toxicity may be replaced.

Entacapone Plus BevacizumabExperimental

Participants randomized to this arm in Stage 2 receive entacapone 400 mg orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. If a treatment-related adverse reaction occurs, entacapone may be reduced to 200 mg three times daily without subsequent dose re-escalation. Oral study treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.

Placebo Plus BevacizumabPlacebo comparator

Participants randomized to this arm in Stage 2 receive matching placebo orally three times daily plus bevacizumab 10 mg/kg intravenously every 2 weeks. If a treatment-related adverse reaction occurs, matching placebo may be reduced to the equivalent of 200 mg three times daily without subsequent dose re-escalation. Oral study treatment may continue for up to 13 cycles (364 days), subject to protocol-defined discontinuation criteria.

Drugs: Entacapone, Bevacizumab, Placebo

Sites

1 site in 1 country

  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, Zhejiang, China