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Primary Myelofibrosis (PMF)Phase 1NCT00910728

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

A Phase 1 study testing AZD1480 in people with Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera, run by AstraZeneca at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 99 years
What is being tested?
AZD1480
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesin 2 countries
Study dates
May 2009to Aug 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • Research Site

    Houston, Texas

  • Research Site

    New York, New York

Other trials in United States

France1 site
  • Research Site

    Villejuif

Other trials in France

About this study

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

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.

Being tested
AZD1480
Keywords
Primary Myelofibrosis (PMF), Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF), Myeloproliferative diseases, Phase I, Phase II, Bone marrow
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1480Drug

    Oral capsule 2.5 mg, 10 mg and 40 mg

Study groups in NCT00910728
Study groupRoleWhat they receive
1ExperimentalAZD1480
Receives: Drug: AZD1480

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic Parameters Following Single Dosing: AUC0-12

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

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

  2. Pharmacokinetic Parameters Following Single Dosing: AUC0-24

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

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

  3. Pharmacokinetic Parameters Following Single Dosing:AUC0-inf

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

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

  4. Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss

    Multiple dose Cmax,ss (ug/L)

    Measured: 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

  5. Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss

    Multiple dose Cmin,ss (ug/L)

    Measured: 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.

  6. Pharmacokinetic Parameters Following Single Dosing: Cmax

    Single dose Cmax (ug/L)

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

  7. Pharmacokinetic Parameters Following Single Dosing: Vz/F

    Single dose Vz/F (L)

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

  8. Pharmacokinetic Parameters Following Single Dosing: CL/F

    Single dose CL/F (L/h)

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

  9. Pharmacokinetic Parameters Following Multiple Dosing: CLss/F

    Multiple dose CLss/F (L/h)

    Measured: 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

  10. Pharamcokinetic Parameters Following Single Dosing: Tmax

    Single dose Tmax (h)

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

  11. Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss

    Multiple dose Tmax,ss (h)

    Measured: 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

  12. Inhibition of PSTAT3 (Count)

    PSTAT3 inhinition

    Measured: 2hrs and 4 hrs post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2012
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910728
Sponsor's protocol ID
D1060C00001
Status last verified
Mar 2017
First submitted
28 May 2009
Last updated
24 Apr 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD1480 in people with Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera, run by AstraZeneca at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.

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