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Completed

NCT Number: NCT00910728

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

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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Key information

Conditions

Primary Myelofibrosis (PMF) Bone Marrow Diseases Essential Thrombocythaemia Myelofibrosis Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Post-Polycythaemia Vera Primary Myelofibrosis

Age range

25 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Villejuif, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1480

Drug

Oral capsule 2.5 mg, 10 mg and 40 mg

Primary outcomes

  1. Pharmacokinetic Parameters Following Single Dosing: AUC0-12

    Time frame: 0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)

    Single dose AUC0-12 (ug*h/L)

  2. Pharmacokinetic Parameters Following Single Dosing: AUC0-24

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose AUC0-24 (ug*h/L)

  3. Pharmacokinetic Parameters Following Single Dosing:AUC0-inf

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose AUC(0 to infinity) (ug*h/L)

  4. Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss

    Time frame: On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10

    Multiple dose Cmax,ss (ug/L)

  5. Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss

    Time frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.

    Multiple dose Cmin,ss (ug/L)

  6. Pharmacokinetic Parameters Following Single Dosing: Cmax

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose Cmax (ug/L)

  7. Pharmacokinetic Parameters Following Single Dosing: Vz/F

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose Vz/F (L)

  8. Pharmacokinetic Parameters Following Single Dosing: CL/F

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose CL/F (L/h)

  9. Pharmacokinetic Parameters Following Multiple Dosing: CLss/F

    Time frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose

    Multiple dose CLss/F (L/h)

  10. Pharamcokinetic Parameters Following Single Dosing: Tmax

    Time frame: 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)

    Single dose Tmax (h)

  11. Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss

    Time frame: On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10

    Multiple dose Tmax,ss (h)

  12. Inhibition of PSTAT3 (Count)

    Time frame: 2hrs and 4 hrs post dose

    PSTAT3 inhinition

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris
  • New York City Hoffman Center
  • University of Texas

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Jun 1, 2009
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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