Back to resultsSafety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Primary Purpose
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NS-018
Sponsored by
About this trial
This is an interventional treatment trial for Primary Myelofibrosis focused on measuring Keywords provided by NS Pharma, Inc.:, JAK2 kinase inhibitor, NS-018, Myeloproliferative Neoplasms, Primary Myelofibrosis, post-Polycythemia Vera Myelofibrosis, post-Essential Thrombocythemia Myelofibrosis, Additional relevant MeSH terms:, Bone Marrow Diseases, Hematologic Diseases, Polycythemia Vera, Thrombocythemia, Essential, PMF, post-PV MF, post-ET MF
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
Sites / Locations
- Mayo Clinic Scottsdale Recruiting
- UC San Diego Moores Cancer Center
- Mayo Clinic, Jacksonville
- Northwestern University
- University of Chicago
- Dana Farber Cancer Institute
- University of Michigan
- Weill Cornell Medical College
- MD Anderson Cancer Center, Department of Leukemia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention: Drug: NS-018
Arm Description
In Phase 1 part, subjects were treated with oral NS-018 at a dose of 75 - 400 mg once daily or 100 - 400 mg twice daily. In Phase 2 part, subjects were treated with oral NS-018 at a dose of 300 mg once daily.
Outcomes
Primary Outcome Measures
Part 1 and Part 2: Number of Subjects With Adverse Events and Serious Adverse Event
AEs (non-serious, serious) as variables of safety and tolerability of NS-018 were assesed. The number of patients were presented as Overall summary of AEs including treatment-emergent AEs (TEAEs); Treatment-emergent SAEs; Drug-related TEAEs; Treatment-emergent AEs leading to permanent discontinuation of study drug; Hospitalization or prolongation of existing hospitalization; Death.
Part 2: Number of Patient With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN)
Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed complete remission (CR) + partial response (PR) + clinical improvement (CI) during the treatment period.
Part 2: Change From Baseline in Spleen Size
Change from baseline in spleen size was assessed by magnetic resonance imaging (MRI) (computed tomography [CT] scan for patients not able to tolerate MRI).
Part 2: Change From Baseline in Bone Marrow Assessment
Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.
Secondary Outcome Measures
Part 1: Number of Patients With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed "complete remission (CR) + partial response (PR) + clinical improvement (CI)" during the treatment period.
Part 1: Change From Baseline in Spleen Size
Change from baseline in spleen size was assessed by palpation.
Part 1: Change From Baseline in Bone Marrow Assessment
Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.
Part 1: Change From Baseline in Quality of Life Assessments Using Myelofibrosis Symptom Assessment Form (MF-SAF)
MF SAF is a 20-item instrument comprised of 4 subscales: 1) the Brief Fatigue Inventory [= average of 9 fatigue scores], 2) Splenomegaly associated symptoms [= average of 4 splenomegaly and associated scores], 3) Catabolic/proliferative Symptoms [= average of 3 catabolic/proliferative associated scores] and 4) Overall Quality of Life. The items were on a scale from 1 to 10 where 1= most favorable, and 10= least favorable.
Part 2: Change From Baseline in Quality of Life Assessments Using Myeloproliferative Neoplasm Symptom Assessment Form (MPN SAF (MPN 10)
Symptoms are evaluated by the MPN-SAF Total Symptom Score (TSS). The MPN-SAF TSS is assessed by the patients themselves and this includes fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Scoring is from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be) for each item. The MPN-SAF TSS is the summation of all the individual scores (0-100 scale). Symptoms response requires >50% reduction in the MPN-SAF TSS.
Part 1 and Part 2: Change in Baseline in Janus Kinase 2 (JAK2) V617F Allele Burden Levels
The JAK2 V617F allele burden mean changes from baseline (%) are presented as pharmacodynamics parameters.
Part 2: Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (Phospho-STAT3)
The Phospho-STAT3 mean changes from baseline (%) are presented as pharmacodynamics parameters.
For phospho-STAT3 values (Phase 2 only), study samples were incubated (± IL-6) and labeled with CD markers. Surface markers included CD3+ (CD4+ [helper T cells] and CD8+ [cytotoxic T cells]) and CD14+ (monocytes) to which intracellular phospho STAT3 was targeted. The levels of phospho-STAT3 in CD14+, CD3+CD4+ and CD3+CD8+ cell subtypes were quantified. Phosphorylated-STAT3 levels were evaluated in the cell types before and after IL-6 incubation (stimulation) and reported both as mean fluorescence intensity (MFI) and the percentage of positive cells. For each sample time point, the MFI was normalized to a fold change.
The fold change was calculated by MFI after IL-6 treatment/MFI before IL-6 treatment. The percent positive cells were normalized by subtracting the percent positive cells before IL-6 treatment from the percent positive cells after IL-6 treatment.
Part1 and Part 2: Observed Maximum Concentration (Cmax)
To determine the Cmax as pharmacokinetic parameters of NS-018.
Part 1 and Part 2: Time to Maximum Plasma Concentration (Tmax)
To determine the Tmax as pharmacokinetic parameters of NS-018.
Part1 and Part 2: Area Under the Plasma Concentration-time Curve (AUC0-24)
To determine the AUC0-24 as pharmacokinetic parameters of NS-018.
Part 1 and Part 2: Terminal Elimination Half-life (t½)
To determine the t½ as pharmacokinetic parameters of NS-018.
Part1 and Part 2: Accumulation Ratio (AR)
To determine the AR as pharmacokinetic parameters of NS-018. AR was calculated as AR = (AUC0-24) Cycle 2 Day 1/ (AUC0-24) Cycle 1 Day 1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01423851
Brief Title
Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
Official Title
A Phase 1/2, Open-label, Dose-Escalation Multi-center Study to Assess the Safety, Tolerability, PK and PD of Orally Administered NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NS Pharma, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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)
Detailed Description
This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis
Keywords
Keywords provided by NS Pharma, Inc.:, JAK2 kinase inhibitor, NS-018, Myeloproliferative Neoplasms, Primary Myelofibrosis, post-Polycythemia Vera Myelofibrosis, post-Essential Thrombocythemia Myelofibrosis, Additional relevant MeSH terms:, Bone Marrow Diseases, Hematologic Diseases, Polycythemia Vera, Thrombocythemia, Essential, PMF, post-PV MF, post-ET MF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Phase 1: 75, 125, 200, 300, 400 mg QD and 100, 200, 250, 300, 400 mg BID Phase 2: 300 mg QD
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Drug: NS-018
Arm Type
Experimental
Arm Description
In Phase 1 part, subjects were treated with oral NS-018 at a dose of 75 - 400 mg once daily or 100 - 400 mg twice daily. In Phase 2 part, subjects were treated with oral NS-018 at a dose of 300 mg once daily.
Intervention Type
Drug
Intervention Name(s)
NS-018
Intervention Description
Treatment will be administered continuously as oral daily therapy in cycles of 4 weeks in duration (28 day treatment cycles).
Primary Outcome Measure Information:
Title
Part 1 and Part 2: Number of Subjects With Adverse Events and Serious Adverse Event
Description
AEs (non-serious, serious) as variables of safety and tolerability of NS-018 were assesed. The number of patients were presented as Overall summary of AEs including treatment-emergent AEs (TEAEs); Treatment-emergent SAEs; Drug-related TEAEs; Treatment-emergent AEs leading to permanent discontinuation of study drug; Hospitalization or prolongation of existing hospitalization; Death.
Time Frame
From screening to until study discontinuation (approximate 8 years 10 months)
Title
Part 2: Number of Patient With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN)
Description
Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed complete remission (CR) + partial response (PR) + clinical improvement (CI) during the treatment period.
Time Frame
Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 2: Change From Baseline in Spleen Size
Description
Change from baseline in spleen size was assessed by magnetic resonance imaging (MRI) (computed tomography [CT] scan for patients not able to tolerate MRI).
Time Frame
From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 2: Change From Baseline in Bone Marrow Assessment
Description
Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.
Time Frame
From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Secondary Outcome Measure Information:
Title
Part 1: Number of Patients With Objective Response Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Description
Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-symptomatic burden were annotated as clinical improvement, anemia response, spleen response, orsymptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The objective response was defined as the number of patients with confirmed "complete remission (CR) + partial response (PR) + clinical improvement (CI)" during the treatment period.
Time Frame
Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 1: Change From Baseline in Spleen Size
Description
Change from baseline in spleen size was assessed by palpation.
Time Frame
From Baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 1: Change From Baseline in Bone Marrow Assessment
Description
Bone marrow was assessed by aspiration and biopsy for grade changes in osteomyelofibrosis. Fibrosis was graded according to European Consensus Myelofibrosis Grading Criteria, ranging from grade 0, which corresponds to normal bone marrow, to grade 3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis.
Time Frame
From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 1: Change From Baseline in Quality of Life Assessments Using Myelofibrosis Symptom Assessment Form (MF-SAF)
Description
MF SAF is a 20-item instrument comprised of 4 subscales: 1) the Brief Fatigue Inventory [= average of 9 fatigue scores], 2) Splenomegaly associated symptoms [= average of 4 splenomegaly and associated scores], 3) Catabolic/proliferative Symptoms [= average of 3 catabolic/proliferative associated scores] and 4) Overall Quality of Life. The items were on a scale from 1 to 10 where 1= most favorable, and 10= least favorable.
Time Frame
From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 2: Change From Baseline in Quality of Life Assessments Using Myeloproliferative Neoplasm Symptom Assessment Form (MPN SAF (MPN 10)
Description
Symptoms are evaluated by the MPN-SAF Total Symptom Score (TSS). The MPN-SAF TSS is assessed by the patients themselves and this includes fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Scoring is from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be) for each item. The MPN-SAF TSS is the summation of all the individual scores (0-100 scale). Symptoms response requires >50% reduction in the MPN-SAF TSS.
Time Frame
From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 1 and Part 2: Change in Baseline in Janus Kinase 2 (JAK2) V617F Allele Burden Levels
Description
The JAK2 V617F allele burden mean changes from baseline (%) are presented as pharmacodynamics parameters.
Time Frame
Part 1 and Part 2: From baseline to Cycle 7 Day 1 (duration of cycle was 4 weeks)
Title
Part 2: Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (Phospho-STAT3)
Description
The Phospho-STAT3 mean changes from baseline (%) are presented as pharmacodynamics parameters.
For phospho-STAT3 values (Phase 2 only), study samples were incubated (± IL-6) and labeled with CD markers. Surface markers included CD3+ (CD4+ [helper T cells] and CD8+ [cytotoxic T cells]) and CD14+ (monocytes) to which intracellular phospho STAT3 was targeted. The levels of phospho-STAT3 in CD14+, CD3+CD4+ and CD3+CD8+ cell subtypes were quantified. Phosphorylated-STAT3 levels were evaluated in the cell types before and after IL-6 incubation (stimulation) and reported both as mean fluorescence intensity (MFI) and the percentage of positive cells. For each sample time point, the MFI was normalized to a fold change.
The fold change was calculated by MFI after IL-6 treatment/MFI before IL-6 treatment. The percent positive cells were normalized by subtracting the percent positive cells before IL-6 treatment from the percent positive cells after IL-6 treatment.
Time Frame
From Baseline to Pre-dose at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)
Title
Part1 and Part 2: Observed Maximum Concentration (Cmax)
Description
To determine the Cmax as pharmacokinetic parameters of NS-018.
Time Frame
Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (duration of cycle was 4 weeks)
Title
Part 1 and Part 2: Time to Maximum Plasma Concentration (Tmax)
Description
To determine the Tmax as pharmacokinetic parameters of NS-018.
Time Frame
Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)
Title
Part1 and Part 2: Area Under the Plasma Concentration-time Curve (AUC0-24)
Description
To determine the AUC0-24 as pharmacokinetic parameters of NS-018.
Time Frame
Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1 (duration of cycle was 4 weeks)
Title
Part 1 and Part 2: Terminal Elimination Half-life (t½)
Description
To determine the t½ as pharmacokinetic parameters of NS-018.
Time Frame
Pre-dose, 0.5 to 24 hours post-dose for Part 1: Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1 and for Part 2: Cycle 1 Day 1, Cycle 2 Day 1 (duration of cycle was 4 weeks)
Title
Part1 and Part 2: Accumulation Ratio (AR)
Description
To determine the AR as pharmacokinetic parameters of NS-018. AR was calculated as AR = (AUC0-24) Cycle 2 Day 1/ (AUC0-24) Cycle 1 Day 1.
Time Frame
Part 1 and Part 2: Cycle 2 Day 1 (duration of cycle was 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdan Verstovsek, M.D., Ph.D.
Organizational Affiliation
MD Anderson Cancer Center, Houston, TX, 77030
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale Recruiting
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
MD Anderson Cancer Center, Department of Leukemia
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27479177
Citation
Verstovsek S, Talpaz M, Ritchie E, Wadleigh M, Odenike O, Jamieson C, Stein B, Uno T, Mesa RA. A phase I, open-label, dose-escalation, multicenter study of the JAK2 inhibitor NS-018 in patients with myelofibrosis. Leukemia. 2017 Feb;31(2):393-402. doi: 10.1038/leu.2016.215. Epub 2016 Aug 1.
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Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
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