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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Myelofibrosis (PMF) Post-Polycythaemia Vera Essential Thrombocythaemia Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

AZD1480

Group Type EXPERIMENTAL

AZD1480

Intervention Type DRUG

Oral capsule 2.5 mg, 10 mg and 40 mg

Interventions

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AZD1480

Oral capsule 2.5 mg, 10 mg and 40 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with myelofibrosis requiring therapy
* Evidence of post-menopausal status or sterile
* ECOG Performance Status \</=2

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No