Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

November 30, 2012

Study Completion Date

October 31, 2013

Conditions
GlioblastomaGiant Cell GlioblastomaGliosarcoma
Interventions
DRUG

XL184

XL184 will be administered daily as a single oral agent supplied as 25- and 100-mg capsules

DRUG

temozolomide

TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules. The starting dose will be 75 mg/m2/day given daily with concurrent RT for 6 weeks

DRUG

temozolomide

TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules. The starting dose will be 200 mg/m2/day given for 5 consecutive days and repeated every 28 days.

RADIATION

Radiation Therapy

Subjects will receive RT consisting of fractionated focal irradiation administered using 1.8-2 Gy/fraction, daily for 5 days/week for 6-7 weeks, for a total dose of up to 60 Gy.

DRUG

temozolomide

TMZ will be supplied as 5-, 20-, 100-, 250-, 140-, and 180-mg capsules.

Trial Locations (8)

10003

Beth Israel Medical Center, New York

22908

University of Virginia Health System/Division of Neuro-Oncology, Charlottesville

27710

Duke University Medical Center; The Preston Robert Tisch Brain Tumor Center, Durham

48202

Henry Ford Health System, Detroit

77030

MD Anderson Cancer Center, Houston

90095

UCLA, Los Angeles

98109

University of Washington, Seattle

02115

Dana-Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Exelixis

INDUSTRY

NCT00960492 - Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma | Biotech Hunter | Biotech Hunter