Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors
- Sponsor
- Rongjie Tao
- Study ID
- NCT03660761
- Phase
- PHASE2
- Status
- Completed
Conditions
- Efficacy and Safety
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- apatinib — DRUGThe 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.
- temodar — DRUGdose-dense temozolomide (100 mg/m2 , 7 days on with 7 days off ) , 28d
Study Details
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.
Key Dates
- Start date
- Mar 3, 2016
- Status verified
- Apr 2019
- Primary completion
- Jan 3, 2017
- Completion
- Jan 6, 2018
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: apatinib 500mg
Primary Outcome Measure
Response to treatment [ Time Frame: up to 3 months ]