Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer
Status:
Withdrawn
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an
oral dual drug with two mechanisms of action:
1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the
sulfamide components
2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety
The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design
first as single agent then combined with radiotherapy:
1. A single agent dose-escalation phase in patients with solid tumours.
2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy
The main objective is to determine the recommended phase II dose of DTP348 in combination
with radiotherapy