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AZD1480

Phase 1

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

AZD1480 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jun 2009

AZD1480 target and mechanism

Molecular targetJAK2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

AZD1480 clinical trials

AZD1480 · 1 trial · 3 indications

Phase 1 1
NCT00910728Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative DiseasesPrimary Myelofibrosis (PMF)
COMPLETED65 Analytics
PHASE1COMPLETED
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Primary Myelofibrosis (PMF)Unlock trial analytics

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 to 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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Frequently asked questions about AZD1480

What is AZD1480 used for?

AZD1480 was studied for the treatment of myeloproliferative diseases, with primary myelofibrosis (PMF) as its lead indication. Its single clinical trial also enrolled patients with post-polycythaemia vera myelofibrosis and essential thrombocythaemia myelofibrosis. It is an investigational agent and is not an approved therapy.

What does AZD1480 target?

AZD1480 targets JAK2, a Janus kinase. It is a small molecule JAK2 inhibitor, meaning it acts by blocking the activity of this kinase. JAK2 inhibition was the intended mechanism in the myeloproliferative disease setting studied for this compound.

Who is developing AZD1480?

AZD1480 was developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The compound is a small molecule JAK2 inhibitor that the company advanced into clinical testing in oncology, specifically in myeloproliferative diseases.

What phase is AZD1480 in?

AZD1480 reached Phase 1 clinical development. It is an investigational drug and has not been approved for any indication. The Phase 1 program has been completed, and no trials of AZD1480 are currently active.

What clinical trials is AZD1480 in?

AZD1480 was evaluated in one completed Phase 1 trial, NCT00910728, titled a study to assess the safety of AZD1480 in patients with myeloproliferative diseases. That trial enrolled 65 patients across the United States and France and included adults aged 25 years and older.

How was the AZD1480 Phase 1 trial designed?

The AZD1480 Phase 1 trial NCT00910728 was an uncontrolled, open-label study, not randomized and not double blinded. It enrolled 65 patients with myeloproliferative diseases, including primary myelofibrosis, post-polycythaemia vera myelofibrosis, and essential thrombocythaemia myelofibrosis, and it has been completed.