Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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 AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Gustave Roussy, Cancer Campus, Grand Paris; New York City Hoffman Center; University of Texas

Criteria

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.