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

Primary Myelofibrosis (PMF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910728
• Other study ID #: D1060C00001
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2009
• Last updated: September 11, 2014
• Start date: May 2009
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Thrombocythaemia Myelofibrosis
• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera
• Post-Polycythaemia Vera
• Primary Myelofibrosis
• Primary Myelofibrosis (PMF)
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• AZD1480
Oral capsule 2.5 mg, 10 mg and 40 mg

Locations

Country	Name	City	State
France	Research Site	Villejuif Cedex
United States	Research Site	Houston	Texas
United States	Research Site	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
AstraZeneca	Gustave Roussy, Cancer Campus, Grand Paris, New York City Hoffman Center, University of Texas

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General assessment of AEs, Pulmonary Function tests and chest CTScan.		Screening, Day 1, Day 10, Day 22, Day 28	Yes
Primary	Pharmacokinetic		Day 1 (pre dose, 0.25hr, 0.5hr, 0.75hr, 1hr, 1.5hr, 2hr,3hr, 4hr, 6hr, 8hr, 12hr and 24hr); Day 28 (pre dose, 0.25hr, 0.5hr, 0.75hr, 1hr, 1.5hr,2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr)	Yes
Secondary	JAK2 Mutation Load		Screening, then only for mutation + patients at the end of Cycle 1	No
Secondary	Laboratory testing		Screening, Day 1, Day 10, Day 22, and Day 28	No
Secondary	Symptoms of myelofibrosis - such as night sweats, fever, fatigue, itching, sweating		Day 1, Day 2, Day 10, Day 22, Day 28	No