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
Overview
- Phase
- Phase 2
- Intervention
- axitinib
- Conditions
- Glioblastoma Multiforme
- Sponsor
- Bart Neyns
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Bart Neyns
MD PhD
Universitair Ziekenhuis Brussel
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Axitinib
axitinib treatment arm
Intervention: axitinib
Axitinib plus Lomustine
Axitinib plus Lomustine
Intervention: Axitinib plus Lomustine
Outcomes
Primary Outcomes
anti-tumor effect of axitinib as a single therapeutic agent and in combination with Lomustine
Time Frame: 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