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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis, Post-Polycythemic Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate safety and tolerability of NS-018 assessed by the type, frequency, seriousness and intensity of adverse events

Outcome Description:

Phase 1 and Phase 2

Outcome Time Frame:

Throughout the study until 30 days after the last dose of study drug (patients with disease progression or no clinical benefit after 6 cycles [168 days] will be discontinued from the study)

Safety Issue:

Yes

Principal Investigator

Srdan Verstovsek, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center, Houston, TX, 77030

Authority:

United States: Food and Drug Administration

Study ID:

NS-018-101

NCT ID:

NCT01423851

Start Date:

June 2011

Completion Date:

December 2013

Related Keywords:

  • Primary Myelofibrosis
  • Post-Polycythemic Vera Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
  • 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
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Northwestern UniversityChicago, Illinois  60611
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
Weill Cornell Medical CollegeNew York, New York  10021
UC San Diego Moores Cancer CenterLa Jolla, California  92093
Mayo Clinic Scottsdale RecruitingScottsdale, Arizona  85259-5499
MD Anderson Cancer Center, Department of LeukemiaHouston, Texas  77030