NCT04501718

Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children

A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Beijing Sanbo Brain Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective single-center clinical study, which aims to observe and evaluate the efficacy and safety of apatinib combined with temozolomide and oral etoposide in the treatment of recurrent medulloblastoma in children.

Detailed description

This research plan is implemented in accordance with GCP principles in Sanbo Brain Hospital of Capital Medical University. Subjects are screened into the group. If the following conditions do not occur (the subject withdraws the informed consent, the drug side effects are intolerable, the investigator thinks it is not suitable for further testing, etc.), the expected research treatment for each subject It will continue until tumor progression or death confirmed by imaging studies, but not more than 2 years. Observe the effectiveness index and safety index during the test.

Conditions

• Recurrent Medulloblastoma

Interventions

Type	Name	Description
DRUG	Apatinib Combined With Temozolomide and Etoposide Capsules	Apatinib mesylate tablets: Oral, 250mg, qd. Take the medicine with warm water half an hour after a meal (the daily medicine should be taken at the same time as possible). 28 days is a cycle, and the medication is administered until the disease progresses (PD), intolerable toxicity occurs or the patient withdraws informed consent. The longest period does not exceed 12 cycles. The treatment after 12 cycles is determined by the investigator.

Timeline

• Start date: 2020-10-28
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2020-08-06
• Last updated: 2024-10-15

Locations

1 site across 1 country: China