Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase I, Three-part Study to Determine the Maximum Tolerated Dose/Recommended Dose (Part 1), Compare Bioavailability in the Fed and Fasted States (Part 2), and Evaluate Safety and Tolerability (Part
Brief Summary:
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.
Part 2 will consist of an initial randomized, open-label, 3-sequence, 3-period, crossover study to evaluate the bioavailability of a single dose of oral ORH-2014 administered in the fed or fasted state (at the MTD or recommended dose identified in Part 1) compared to a single dose of IV Trisenox administered at a dose of 0.15 mg/kg.
Part 3 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 MTD or recommended dose. Subjects with the same disease types as in Part 1 will be enrolled. All subjects will receive oral ORH-2014 at the MTD or recommended dose for an initial period of up to 12 weeks.