Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT01423851 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-109

 

The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Martha Wadleigh, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: - Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy - ≥18 years old - ECOG Performance Status of ≤2 - Estimated life expectancy of ≥12 weeks - Male or non-pregnant, non-lactating female patients - Serum creatinine of ≤1.5 × the upper limit of normal (ULN)OR estimated creatinine clearance (CrCl) ≥60 ml/min/1.73 m2 - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × the upper limit of normal (ULN) and total bilirubin ≤1.5 × ULN - Absolute neutrophil count (ANC) >1000/μL and Platelet count >50,000/μL - QTcB ≤480 msec - No MF-directed treatment for at least 2 weeks prior to initiation of NS-018 Exclusion Criteria: - Active, uncontrolled systemic infection - Patients with any unresolved toxicity greater than Grade 1 from previous anticancer therapy - Potentially curative therapy is available - Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 or taking medication known to be strong inhibitors or inducers of CYP3A4 - Patients with a serious cardiac condition within the past 6 months - Pregnant or lactating - Radiation therapy for splenomegaly within 6 months prior to study entry - Splenectomy (Phase 2 portion of the study only) - Known HIV positive status - Known active hepatitis, a history of viral hepatitis B or hepatitis C, or known positive hepatitis B serologies without a history of immunization
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