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 — DRUG
    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.
  • temodar — DRUG
    dose-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 ]