Trials / Completed
CompletedNCT00884416
Sorafenib in Newly Diagnosed High Grade Glioma
Phase I Dose Finding Study of Sorafenib in Combination With Radiation Therapy and Temozolomide as a First Line Treatment of Patients With High Grade Glioma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University Hospital, Geneva · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination with Temodar and radiation therapy in patients with newly diagnosed high grade glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes it an interesting drug to investigate in the treatment of patients with high grade glioma as this agent has anti-angiogenic activity and inhibits other pathways such as Ras, Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which are potential targets against gliomas.
Detailed description
Up to 18 patients will be included in this phase I study. The primary goal of this study will be to establish the maximum tolerated dose of sorafenib when used in combination with temozolomide and radiation therapy. Secondary goals of this study include: response rate, time to treatment failure, 6 month progression-free survival, event free survival and overall survival. A correlative study will investigate the pharmacokinetics of sorafenib used in combination with radiation therapy and temozolomide.
Conditions
- Glioblastoma
- Gliosarcoma
- Anaplastic Astrocytoma
- Anaplastic Oligoastrocytoma
- Anaplastic Oligodendroglioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib dose escalation | Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2011-12-01
- Completion
- 2012-03-01
- First posted
- 2009-04-20
- Last updated
- 2014-11-04
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT00884416. Inclusion in this directory is not an endorsement.