Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma
Status:
Completed
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
Glioblastomas are extremely resistant to treatment, including radiotherapy and/or
chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways
involved in the regulation of normal cell proliferation, survival and differentiation.
Activation of p38 MAPK has been associated with a poor prognosis among patients with
glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by
tumor cell to environmental stress such as radiation or chemotherapy.
LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its
cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate
to target malignant glioma resistance to the gold standard treatment combining radiation and
TMZ by acting on both tumor and stromal cells.
The primary objectives of this study were to determine the recommended dose of LY2228820 in
combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to
estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820
when administered at the recommended dose in combination with radiotherapy and concomitant
TMZ (phase II)
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Centre Jean Perrin
Collaborators:
ARC Foundation for Cancer Research National Cancer Institute, France