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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910728
First Posted: June 1, 2009
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Texas
New York City Hoffman Center
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Primary Myelofibrosis (PMF) Post-Polycythaemia Vera Essential Thrombocythaemia Myelofibrosis Drug: AZD1480 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Inhibition of PSTAT3 (Count) [ Time Frame: 2hrs and 4 hrs post dose ]
    PSTAT3 inhinition


Enrollment: 65
Study Start Date: May 2009
Study Completion Date: August 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1480
Drug: AZD1480
Oral capsule 2.5 mg, 10 mg and 40 mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910728


Locations
United States, New York
Research Site
New York, New York, United States
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Villejuif Cedex, France
Sponsors and Collaborators
AstraZeneca
University of Texas
New York City Hoffman Center
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Srdan Verstovsek, MD MDACC
Principal Investigator: Ronald Hoffman, MD Mt. Sinai
Principal Investigator: Vincent Ribrag, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Director: Becker Hewes, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00910728     History of Changes
Other Study ID Numbers: D1060C00001
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 18, 2015
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: March 2017

Keywords provided by AstraZeneca:
Primary Myelofibrosis (PMF)
Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF)
Myeloproliferative diseases
Phase I
Phase II
Bone marrow

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders


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