A randomized study to comparelomustine with lomustine and bevacizumab for patients with recurrent malignant brain tumors.
Phase 1
- Conditions
- recurrent glioblastomaMedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003545-11-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
•Histological verified glioblastoma
•Recurrent GBM, previously treated according the STUPP regimen
•PS 0-1
•Age > 18
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
Exclusion Criteria
•Previous therapy of recurrent GBM including temozolomide reinduction.
•Previous use of biological drug targeting the VEGF-signaling pathway
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method