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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Orsenix LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Female and male subjects ≥18 years of age with one of the following:
* Relapsed or refractory acute myelocytic leukemia (AML) with nucleophosmin-1 (NPM1) mutations and no available therapies.
* Relapsed or refractory acute promyelocytic leukemia (APL), with no available therapies. Note: Prior exposure to arsenic trioxide is allowed; however, subjects who have failed arsenic trioxide within the last 12 months are not allowed.
* Relapsed or refractory myelodysplastic syndrome (MDS), International Prognostic Scoring System intermediate or high-risk, with no available therapies
* Relapsed or refractory chronic myelomonocytic leukemia (CMML), and other MDS/myeloproliferative neoplasm (MPN) overlap syndromes, with no available therapies
* Relapsed or refractory mantle cell lymphoma (MCL) with no adequate therapies.
Negative pregnancy test at the Screening visit for women of childbearing potential and willingness to use adequate birth control
Not willing to undergo, not a candidate for, or not having a donor for immediate (within 3 months from the Screening date) bone marrow transplantation.
You may not be if
Eastern Cooperative Oncology Group performance status of ≥3;
Absolute myeloblast count ≥20,000/mm\^3;
Administration of any antineoplastic therapy within 5 half-lives of the antineoplastic therapy before the first dose of ORH-2014, with the exception of hydroxyurea that should be discontinued 1 day prior to the first dose of ORH-2014
Presence of any remaining toxicities due to previous chemotherapy
Participation in other clinical trials within at least 2 weeks of the first ORH-2014 dose;
Clinical evidence of active central nervous system leukemia;
Active and uncontrolled infection
Major surgery within 2 weeks prior to trial entry;
Liver function tests above the following limits at Screening: total bilirubin \>1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysis; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x ULN; for subjects with liver involvement, AST and/or ALT \>5 x ULN;
Serum creatinine \>1.5 x ULN and/or creatinine clearance or estimated glomerular filtration rate \<30 mL/min
Impaired cardiac function
Myocardial infarction of unstable angina within 6 months prior to the planned start date of study drug.
Clareo Health | 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
