Advanced Hematological Disorders Clinical Trial
Official title:
A Phase I, Two-part Study to Determine the Recommended Dose and Evaluate the Safety and Tolerability of a Novel Oral Arsenic Trioxide Formulation (ORH-2014) in Subjects With Advanced Hematological Disorders
Part 1 will be conducted as an open-label, non-randomized, non-placebo-controlled dose
escalation study using pre-specified doses. Subjects with the following advanced
hematological disorders and no available therapies, and who satisfy all inclusion/exclusion
criteria will be enrolled. The purpose is to identify the recommended dose of oral ORH-2014
in subjects with advanced hematological disorders.
Part 2 will be an expansion phase conducted as a single-arm, open-label study to further
evaluate the safety and tolerability of ORH-2014 at the maximum tolerated dose (MTD) or
recommended dose determined from Part 1 in the fasted state. Subjects with the same disease
types as in Part 1 will be enrolled. All subjects will receive oral ORH-2014, in the fasted
state, at the recommended dose for an initial period of up to 12 weeks. The purpose is to
evaluate the safety and tolerability of oral ORH-2014 in a population of subjects with
advanced hematological disorders when administered at the recommended dose.
n/a