A Phase 1 Dose Finding Study of the Safety and Pharmacokinetics of XL184 Administered Orally in Combination with Temozolomide and Radiation Therapy in the First Line Treatment of Subjects with Glioblastoma

IRB-HSR# 14459
Service: Cancer | Category: Cancer
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: David Schiff, M.D.

Contact Information

Contact: Goga Radakovic
Phone: 434.243.5750
E-mail: gr2p@virginia.edu

Clinical Trial Description

Glioblastoma multiforme (GBM) is a malignant brain tumor. Unfortunately, there is no cure for this disease and many people die within 12-15 months. GBM is the second leading cause of death from cancers in people under the age of 35 and the fourth leading cause in those under the age of 54. The usual treatments include surgery, radiation and chemotherapy.

In this study, researchers will be looking to determine the highest dose of XL184 that can be safely taken when added to radiation therapy and temozolomide. Researchers will also determine how well this combination works. Participants will have a routine history and physical exam performed, routine blood tests, and tumor evaluations by magnetic resonance imaging (MRI).

You may qualify for the study is you:

• Are a male or non-pregnant female age 18 or older
• Have had surgical removal of the tumor. (Note: you must start study treatment greater than 4 weeks after, but less than 49 days weeks after surgery)
• Are willing to practice effective method of birth control during study participation

You may not qualify for this study if you have/had:

• Other active cancers requiring therapy to control disease
• Prior chemotherapy or radiation therapy for any brain tumor

OR you are

• Receiving any other investigational agents
• Pregnant women or nursing women

Compensation

You will receive no money for being part of this study. Study drug will be provided by the study sponsor, Exelixis, Inc.