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

Open Label INCB018424 in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

This study is currently recruiting participants.
Verified by Incyte Corporation, February 2008

Sponsored by:	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

Genetics Home Reference related topics:

hemophilia

U.S. FDA Resources

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)

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:	50
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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, Texas
		Recruiting
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Incyte Corporation

More Information

Responsible Party:	Incyte Corporation ( Incyte Corporation )
Study ID Numbers:	INCB 18424-251
First Received:	July 30, 2007
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00509899
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Polycythemia

Polycythemia Vera

Essential thrombocytosis

Myelofibrosis

Hematologic Diseases

Blood Coagulation Disorders

Blood Platelet Disorders

Myeloproliferative Disorders

Polycythemia vera

Hemostatic Disorders

Thrombocytopathy

Hemorrhagic Disorders

Hemorrhagic thrombocythemia

Thrombocytosis

Thrombocythemia, Hemorrhagic

Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 30, 2008