Open Label INCB018424 in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis - Full Text View

Sponsor:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00509899

Purpose

Open label study of INCB018424 in patients with Primary Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Condition	Phase
Myelofibrosis Polycythemia Vera Thrombocytosis	Phase I Phase II

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Phase 1/2 , Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Spleen Diseases

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events, physical exams, evaluating changes in vital signs and ECGs, and through clinical laboratory blood and urine sample evaluation. [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To study preliminary effectiveness of oral INCB018424 in a patient population diagnosed with PMF and Post-PV/ET MF. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Plasma

Estimated Enrollment:	158
Study Start Date:	June 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Detailed Description:

This is a multicenter, open-label, non-randomized, dose escalation study of INCB018424, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts:

Part 1: Dose escalation and determination of maximum tolerated dose (complete).

Part 2: Exploration of alternative dosing schedules (ongoing).

Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of INCB018424 on symptoms and other parameters including daily physical activity (ongoing).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Myelofibrosis Polycythemia Vera Thrombocytosis

Criteria

Inclusion Criteria:

Diagnosed with PMF or Post-PV/ET MF
Patients with myelofibrosis requiring therapy
Adequate bone marrow reserve

Exclusion Criteria:

Received anti-cancer medications or investigational therapy in the past 14 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509899

Contacts

Contact: Sara Malhotra, Ph.D.

302-498-6830

smalhotra@incyte.com

Locations

United States, Minnesota
	Active, not recruiting
Rochester, Minnesota, United States
United States, Texas
	Recruiting
Houston, Texas, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

Principal Investigator:	Srdan Verstovsek, MD, PhD	M.D. Anderson Cancer Center, Houston, TX
Principal Investigator:	Ayalew Tefferi, MD	Mayo Clinic, Rochester, MN

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Incyte Corporation )
Study ID Numbers:	INCB 18424-251
Study First Received:	July 30, 2007
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00509899 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Polycythemia
Polycythemia Vera
Myelofibrosis
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders

Myeloid Metaplasia
Lymphatic Diseases
Hemorrhagic Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on February 08, 2010