Clinical trial
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
Name
ASC40-301
Description
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.
Trial arms
Trial start
2022-01-21
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
ASC40 tablets
ASC40 tablets administered orally once daily
Arms:
ASC40
Other names:
TVB-2640
Placebo tablets
Placebo administered orally once daily.
Arms:
Placebo
Bevacizumab
Bevacizumab once every 2 weeks, intravenous drip.
Arms:
ASC40, Placebo
Size
180
Primary endpoint
Progression-free survival
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
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
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2024-04-03
1 organization
3 products
1 indication
Product
ASC40Indication
GlioblastomaOrganization
Ascletis PharmaceuticalsProduct
BevacizumabProduct
Placebo