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Sorafenib in Newly Diagnosed High Grade Glioma

NCT00884416 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-11-04

No results posted yet for this study

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.

Conditions

  • Glioblastoma
  • Gliosarcoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligoastrocytoma
  • Anaplastic Oligodendroglioma

Interventions

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Pierre-Yves Dietrich, MD · Department of oncology, Geneva University hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00884416 on ClinicalTrials.gov