Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
brief summary
The study is designed as an open label, multi-center, Phase 1 study of single agent tinostamustine, used as adjuvant treatment in patients with newly diagnosed GBM who are MGMT unmethylated and have completed concomitant treatment with temozolomide and radiation. Treatment with adjuvant tinostamustine will start within 5 weeks of completion of concomitant temozolomide and radiation. The study is designed to define the MTD by evaluating toxicities during dose escalation. Tinostamustine will be administered on Day 1 of a 21-day treatment cycle. The total number of treatment cycles is 12 for patients who continue to benefit from treatment without disease progression or intolerable toxicity. Patients will enter a "3+3" design with dose escalation/de-escalation depending on safety from the last treated cohort.
official title
A Phase 1 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Tinostamustine, a Novel Alkylating and Deacetylase Inhibiting Molecule, as Adjuvant Treatment in Patients With Newly Diagnosed Unmethylated MGMT-promoter Glioblastoma