A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma
- Conditions
- Glioblastoma Multiforme
- Interventions
- Registration Number
- NCT01562197
- Lead Sponsor
- Bart Neyns
- Brief Summary
This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1:1 randomization). Patients randomized to the Axitinib treatment-arm will be treated with Axitinib until progression (they can be treated after progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or patients refusal to continue study treatment. Patients randomized to the Axitinib plus Lomustine-arm will receive treatment until progression, unacceptable treatment related toxicity, or patients refusal to continue study treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Axitinib axitinib axitinib treatment arm Axitinib plus Lomustine Axitinib plus Lomustine Axitinib plus Lomustine
- Primary Outcome Measures
Name Time Method anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine 6months To estimate the anti-tumor effect of axitinib as a single therapeutic agent for the treatment of glioblastoma patients at the time of recurrence/progression following prior surgery, radiation and alkylating chemotherapy and in combination with Lomustine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Brussel
🇧🇪Brussel, Belgium