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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 2, 2016

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions
Advanced Hematological Disorders
Interventions
DRUG

ORH-2014

ORH-2014 capsule 5 mg orally with dose escalations of 5 mg intervals.

DRUG

ORH-2014

ORH-2014 capsule at recommended dose orally.

Trial Locations (4)

10065

Memorial Sloan-Kettering Cancer Center, New York

Weill Cornell Medical College, New York

37240

Vanderbilt University, Nashville

77030

MD Anderson, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Orsenix LLC

INDUSTRY