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

Recurrent Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118776
• Other study ID #: ASC40-301
• Status: Recruiting
• Phase: Phase 3
• Start date: January 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: Wenbin Li, Doctor
• Phone: 86-010-59975034
• Email: neure55[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

Drug:
• ASC40 tablets
ASC40 tablets administered orally once daily
• Placebo tablets
Placebo administered orally once daily.
• Bevacizumab
Bevacizumab once every 2 weeks, intravenous drip.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	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
Primary	Total survival	the time from random grouping to death, compared with the control group.	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	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]).	Week 4 to Month 6 (every 8 weeks)