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AZD1480

Phase 1

Primary Myelofibrosis (PMF) | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 24, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00910728Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative DiseasesPHASE1 COMPLETED 65 — — May 1, 2009Aug 1, 2014Apr 24, 20173 United States, France
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Study Endpoints
Primary Endpoints
Pharmacokinetic Parameters Following Single Dosing: AUC0-12
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
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
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
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
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
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
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
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
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
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
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)
2hrs and 4 hrs post dose

PSTAT3 inhinition

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD1480
Interventions
NameTypeDescription
AZD1480DRUGOral capsule 2.5 mg, 10 mg and 40 mg
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Eligibility Criteria
Age Range25 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 ...

Countries:United StatesFrance
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