Status:
COMPLETED
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
University of Texas
New York City Hoffman Center
Conditions:
Primary Myelofibrosis (PMF)
Post-Polycythaemia Vera
Eligibility:
All Genders
25-99 years
Phase:
PHASE1
Brief Summary
This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1...
Eligibility Criteria
Inclusion
- Patients with myelofibrosis requiring therapy
- Evidence of post-menopausal status or sterile
- ECOG Performance Status \</=2
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00910728
Start Date
May 1 2009
End Date
August 1 2014
Last Update
April 24 2017
Active Locations (3)
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1
Research Site
New York, New York, United States
2
Research Site
Houston, Texas, United States
3
Research Site
Villejuif, France