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
25 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis (PMF), Post-Polycythaemia Vera, Essential Thrombocythaemia Myelofibrosis
Both
Primary Myelofibrosis (PMF), Post-Polycythaemia Vera, Essential Thrombocythaemia Myelofibrosis
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 Site | Albany, New York |
| Research Site | Abilene, Texas |
