Recurrent Glioblastoma
Conditions
Keywords
ASC40, Recurrent Glioblastoma
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.
Interventions
DRUGASC40 tablets
ASC40 tablets administered orally once daily
DRUGPlacebo tablets
Placebo administered orally once daily.
DRUGBevacizumab
Bevacizumab once every 2 weeks, intravenous drip.
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate | Week 4 to Month 6 (every 8 weeks) | 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 \[IRC\]). |
Countries
China
Outcome results
None listed