Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Phase I:
Primary Objectives:
-To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and
6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m^2/day in patients with
newly-diagnosed glioblastoma (GBM).
Secondary Objectives:
- To characterize the safety profile of dasatinib (Sprycel) in combination with
radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM.
- To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant
TMZ in patients with glioblastoma after RT.
STUDY DID NOT PROGRESS TO PHASE II PORTION.
Phase II:
Primary Objectives:
-To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of
concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant
temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as
measured by overall survival.
Secondary Objectives:
- To determine the efficacy of this treatment as measured by radiographic response (RR),
progression-free survival (PFS) and time to progression (TTP).
- To characterize the safety profile of dasatinib (Sprycel) in combination with RT and
concomitant TMZ in patients with newly-diagnosed GBM.
- To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant
TMZ in patients with GBM after RT.
Exploratory Objectives:
-To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2,
c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.