A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma
Overview
- Phase
- Phase 3
- Intervention
- Bevacizumab
- Conditions
- Recurrent Glioblastoma
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old, both male and female;
- •Histologically confirmed glioblastoma;
- •Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles.
Exclusion Criteria
- •Use low molecular weight heparin and warfarin within 35 days before randomization;
- •Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization
Arms & Interventions
ASC40
ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.
Intervention: Bevacizumab
ASC40
ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.
Intervention: ASC40 tablets
Placebo
Placebo and bevacizumab 10mg/kg.
Intervention: Placebo tablets
Placebo
Placebo and bevacizumab 10mg/kg.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
The time of progression or death from any cause in randomly grouped diseases (whichever comes first) was compared with the control group (evaluated by Independent Imaging Evaluation Committee \[IRC\])
Total survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
the time from random grouping to death, compared with the control group.
Secondary Outcomes
- Objective remission rate(Week 4 to Month 6 (every 8 weeks))