Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01423851
Eligibility Criteria:
Inclusion Criteria:
* Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
* MF patients must have received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, based on investigator assessment
* ≥18 years old
* ECOG Performance Status of ≤ 3
* 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) ≥ 40 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. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ≤ 1.5 X ULN are eligible during the Phase II portion.
* Absolute neutrophil count (ANC) \>1000/μL and Platelet count \> 25,000/μL
* QTcB ≤ 480 msec
* No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ≤ 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423851
Study Brief:
Protocol Section:
NCT01423851