Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05118776

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Recurrent Glioblastoma Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tiantan Hospital，Capital Medical University

Beijing, Beijing Municipality, 100071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC40 tablets

Drug

ASC40 tablets administered orally once daily

Other names: TVB-2640

Placebo tablets

Drug

Placebo administered orally once daily.

Bevacizumab

Drug

Bevacizumab once every 2 weeks, intravenous drip.

Primary outcomes

  1. 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])

  2. 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

  1. Objective remission rate

    Time frame: 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]).

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.