A Study Exploring New Therapies for Newly Diagnosed Glioblastoma

Full Title

INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT)

Purpose

Glioblastomas that have an “unmethylated” MGMT gene are less likely to respond to the standard chemotherapy drug temozolomide. In this study, researchers are comparing three investigational treatments (abemaciclib, CC-115, and neratinib) with the standard treatment (temozolomide and radiation therapy) in patients newly diagnosed with glioblastoma.

Patients in this study will receive one of these treatment regimens:

  • Conventional treatment with temozolomide and radiation therapy followed by abemaciclib, a drug used to treat breast cancer which inhibits tumor growth by blocking certain enzymes called CDKs that cancer cells use to grow and divide
  • Radiation therapy plus CC-115 (a drug designed to inhibit the growth of cancer cells by blocking an enzyme cancer cells need called DNA-PK and a protein called mTOR) followed by CC-115 alone
  • Temozolomide and radiation therapy followed by neratinib, a drug that blocks abnormal HER2, a protein some cancer cells use to grow
  • Temozolomide and radiation therapy followed by temozolomide alone

All of the medications used in this study are taken orally (by mouth).

Protocol
19-138
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT02977780