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

This study has been completed.
Sponsor:
Collaborators:
University of Texas
New York City Hoffman Center
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00910728
First received: May 28, 2009
Last updated: September 11, 2014
Last verified: September 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • General assessment of AEs, Pulmonary Function tests and chest CTScan. [ Time Frame: Screening, Day 1, Day 10, Day 22, Day 28 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic [ Time Frame: 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • JAK2 Mutation Load [ Time Frame: Screening, then only for mutation + patients at the end of Cycle 1 ] [ Designated as safety issue: No ]
  • Laboratory testing [ Time Frame: Screening, Day 1, Day 10, Day 22, and Day 28 ] [ Designated as safety issue: No ]
  • Symptoms of myelofibrosis - such as night sweats, fever, fatigue, itching, sweating [ Time Frame: Day 1, Day 2, Day 10, Day 22, Day 28 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00910728     History of Changes
Other Study ID Numbers: D1060C00001
Study First Received: May 28, 2009
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 25, 2014