Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

Timeline

Start

2009-06

Primary completion

2014-10

Completion

2019-11-15

Outcome

Missed primary endpoint

paper OS was not different between arms (median OS 15.6 months for dasatinib compared to 19.3 months for placebo, hazard ratio:1.21 favoring placebo, 95% CI: 0.88-1.65, log-rank P-value: .238). PMID 40579995 ↗

Publications

• Breen WG, Dixon JG, Anderson SK, Sarkaria JN, Brown PD, Yan ES, Kizilbash S, Galanis E, Anderson D, Tran D, Mazurczak M, Johnson DR, Geoffroy FJ, Leinweber C, Laack NN. Final report on North Central Cancer Treatment Group N0877 (alliance): A phase II randomized, placebo-controlled trial of chemoradiotherapy with or without dasatinib for glioblastoma. Neuro Oncol. 2025 Oct 1;27(10):2661-2670. doi: 10.1093/neuonc/noaf156.

Drugs

Indications