Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM

Phase 3Active Not RecruitingNCT05118776

Ascletis Pharmaceuticals Co., Ltd.136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Recurrent Glioblastoma

Interventions

ASC40 tabletsDRUG

ASC40 tablets administered orally once daily

Placebo tabletsDRUG

Placebo administered orally once daily.

BevacizumabDRUG

Bevacizumab once every 2 weeks, intravenous drip.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Age ≥18 years old, both male and female; * 2\. Histologically confirmed glioblastoma; * 3\. 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: * 1\. Use low molecular weight heparin and warfarin within 35 days before randomization; * 2\. 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

Locations (1)

Beijing Tiantan Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Progression-free survival

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 \[IRC\])

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

Total survival

the time from random grouping to death, compared with the control group.

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

Secondary Outcomes

Objective remission rate

It is evaluated once in the 4th week after using experimental drugs (experimental drug group or control group), and then every 8 weeks until the disease progresses or dies (evaluated by \[IRC\]).

Time frame: Week 4 to Month 6 (every 8 weeks)

Data from ClinicalTrials.gov

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