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A PhaseI/II, Open Label Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF


Phase 1/Phase 2
25 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis (PMF), Post-Polycythaemia Vera, Essential Thrombocythaemia Myelofibrosis

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Trial Information

A PhaseI/II, Open Label Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF


Inclusion Criteria:



- Patients with myelofibrosis requiring therapy

- Evidence of post-menopausal status or sterile

- ECOG Performance Status
Exclusion Criteria:

- Prior therapy with any JAK2 medications

- Significant lung disorder or lung disease

- Previous radiation therapy to chest wall or chest infection requiring antibiotic
treatment within 28 days before study screening

- Eye disease of the cornea

- Patients requiring oxygen supplementation

- Ejection fraction <45% (ECHO/MUGA) or significant pulmonary hypertension >40 mm Hg
(by Echo/Doppler)

- Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <70% predicted or >130%
predicted

- Diffusing capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin
<60% predicted, oxygen saturation <88% at rest or after a 6-minute flat walk, without
supplemental oxygen

- Chest infection requiring antibiotics within 7 days of the first dose of
Investigational product.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

General assessment of AEs, Pulmonary Function tests and chest CTScan.

Outcome Time Frame:

Screening, Day 1, Day 10, Day 22, Day 28

Safety Issue:

Yes

Principal Investigator

Srdan Verstovsek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MDACC

Authority:

United States: Food and Drug Administration

Study ID:

D1060C00001

NCT ID:

NCT00910728

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Primary Myelofibrosis (PMF)
  • Post-Polycythaemia Vera
  • Essential Thrombocythaemia Myelofibrosis
  • Primary Myelofibrosis (PMF)
  • Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF)
  • Myeloproliferative diseases
  • Phase I
  • Phase II
  • Bone marrow
  • Primary Myelofibrosis
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

Research SiteAlbany, New York  
Research SiteAbilene, Texas