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	Intervention	Phase
Myelofibrosis Polycythemia Vera Thrombocytosis	Drug: INCB018424 tablets	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: essential thrombocythemia hemophilia MYH9-related disorder polycythemia vera primary myelofibrosis

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Number of participants with adverse events. [ Time Frame: Measured monthly starting at baseline. (Estimated duration 36 months). ] [ Designated as safety issue: Yes ]
Change from baseline in spleen and liver volume by MRI. [ Time Frame: Measured monthly starting at baseline, completion of 1 month, 3 month, 6 month and subsequently 6 month intervals. ] [ Designated as safety issue: No ]
Change from baseline in body weight. [ Time Frame: Measured monthly starting at baseline for the first three months and subsequently quarterly (Estimated duration 36 months). ] [ Designated as safety issue: No ]
Analysis of clinical response (defined as clinical complete remission (CR), clinical partial remission (PR) or clinical improvement (CI), as summarized by assessments visits. [ Time Frame: Measured quarterly starting at baseline. (Estimated duration 36 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline of the quality of life assessment. [ Time Frame: Measured monthly starting at baseline for the three months and subsequently quarterly. (Estimated duration 36 months). ] [ Designated as safety issue: No ]

Enrollment:	158
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INCB018424 Open Label; All patients are receiving active compound (INCB018424)	Drug: INCB018424 tablets 5 and 25 mg tablets with a daily dosing range from 10 to 200 mg bid or qd.

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

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

Locations

United States, Minnesota

Rochester, Minnesota, United States
United States, Texas

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 by Incyte Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27.

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00509899 History of Changes
Other Study ID Numbers:	INCB 18424-251
Study First Received:	July 30, 2007
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders

Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on February 09, 2012