Blood and Lymph Conditions

All Conditions

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Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

AZD1480

Srdan Verstovsek, MD

Ronald Hoffman, MD

Vincent Ribrag, MD

Becker Hewes, MD

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.

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

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

University of Texas

New York City Hoffman Center

Gustave Roussy, Cancer Campus, Grand Paris

AstraZeneca

AZD1480 may be administered orally in capsules

2.5 mg QD

5.0 mg QD

10 mg QD

70 mg QD

15 mg BID

20 mg QD

30 mg QD

50 mg QD

10 mg BID

Total

Age, Continuous

Sex: Female, Male

Dr Gregory Curt, MD

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Pharmacokinetic Parameters Following Single Dosing: AUC0-12

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated.

Pharmacokinetic Parameters Following Single Dosing: AUC0-24

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute.

Pharmacokinetic Parameters Following Single Dosing:AUC0-inf

Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss

Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss

Pharmacokinetic Parameters Following Single Dosing: Cmax

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups.

Pharmacokinetic Parameters Following Single Dosing: Vz/F

Pharmacokinetic Parameters Following Single Dosing: CL/F

Pharmacokinetic Parameters Following Multiple Dosing: CLss/F

Pharamcokinetic Parameters Following Single Dosing: Tmax

Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss

2 Hours post dose

4 Hours post dose

Inhibition of PSTAT3 (Count)

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

AZD1480 until Maximum Tolerated Dose (MTD) is reached

Gregory Curt, MD

This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.

Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases	NCT00910728	Primary Myelofi... Post-Polycythae... Essential Throm...	AZD1480	25 Years - 99 Years	AstraZeneca
Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours	NCT01112397	Solid Malignanc...	AZD1480	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for azd1480

Every month we try and update this database with for azd1480 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd1480

Every month we try and update this database with for azd1480 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd1480 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.