NCT03660761

Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors

Efficacy and Safety of Apatinib Combined With Dose-dense Temozolomide in Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Rongjie Tao · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy.

Detailed description

The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy. Brain MRI+MRS was examined every 3 months; Blood routine, urine routine and liver and kidney function were examined once a week.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	apatinib	The patient was given a daily dose of apatinib 500mg (or based on weight). For adult, the dose of apatinib was prescribed with 425 mg or 500 mg per day and four weeks for a cycle. The dosage was modified to 250 mg if patients experienced ≧grade 2 hematologic adverse events, hand and foot syndrome, proteinuria, fecal ocular blood, or grade 3/4 hypertension, or other grade 3/4 adverse events. Apatinib was administrated until disease progression, unacceptable toxicity or death.
DRUG	temodar	dose-dense temozolomide (100 mg/m2 , 7 days on with 7 days off ) , 28d

Timeline

• Start date: 2016-03-03
• Primary completion: 2017-01-03
• Completion: 2018-01-06
• First posted: 2018-09-07
• Last updated: 2019-04-16

Locations

1 site across 1 country: China