Apatinib Combined With Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children
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|ClinicalTrials.gov Identifier: NCT04501718|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Medulloblastoma||Drug: Apatinib Combined With Temozolomide and Etoposide Capsules||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined With Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||August 31, 2024|
|Estimated Study Completion Date :||August 31, 2024|
|Experimental: Test group||
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.
- Objective Response Rate (ORR) [ Time Frame: up to 4 years ]
- Progression-free survival (PFS) [ Time Frame: up to 4 years ]
- Overall survival (OS) [ Time Frame: up to 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501718
|Contact: Jun-ping Zhangfirstname.lastname@example.org|
|Beijing Sanbo Brain Hospital||Recruiting|
|Contact: Jun-ping Zhang 86-010-62856798|