Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
Status:
Not yet recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
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.