Phase 1
N=35
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Primary Myelofibrosis (PMF) · Post-Polycythaemia Vera · Essential Thrombocythaemia Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00910728 ↗Enrolled (actual)
35
Serious AEs
42.9%
Results posted
Apr 2017
Primary outcome: Primary: Pharmacokinetic Parameters Following Single Dosing: AUC0-12 — 69.2; 295; 278; 1860 ug*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AZD1480 (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameters Following Single Dosing: AUC0-12 |
69.2; 295; 278; 1860; 5800; 425 | — |
| PRIMARY Pharmacokinetic Parameters Following Single Dosing: AUC0-24 |
70.2; 308; 285; 2000; 6260; 3540 | — |
| PRIMARY Pharmacokinetic Parameters Following Single Dosing:AUC0-inf |
83.5; 312; 378; 2040; 6300; 3650 | — |
| PRIMARY Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss |
51.3; 134; 176; 658; 1500; 218 | — |
| PRIMARY Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss |
69.2; 295; 278; 1860; 5800; 425 | — |
| PRIMARY Pharmacokinetic Parameters Following Single Dosing: Cmax |
69.9; 133; 157; 739; 2600; 273 | — |
| PRIMARY Pharmacokinetic Parameters Following Single Dosing: Vz/F |
222; 108; 138; 97; 57.9; 105 | — |
| PRIMARY Pharmacokinetic Parameters Following Single Dosing: CL/F |
35.2; 16; 34.8; 14.7; 11.1; 22.6 | — |
| PRIMARY Pharmacokinetic Parameters Following Multiple Dosing: CLss/F |
37.8; 15.8; 30.1; 17; 9.57; 20 | — |
| PRIMARY Pharamcokinetic Parameters Following Single Dosing: Tmax |
0.625; 0.75; 0.75; 1; 0.75; 0.625 | — |
| PRIMARY Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss |
0.5; 0.78; 0.77; 0.75; 1.5; 1 | — |
| PRIMARY Inhibition of PSTAT3 (Count) |
0; 0; 0; 1; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with myelofibrosis requiring therapy
- Evidence of post-menopausal status or sterile
- ECOG Performance Status 40 mm Hg (by Echo/Doppler)
- Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) 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.
Data sourced from ClinicalTrials.gov (NCT00910728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.