Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia - Full Text View

Sponsor:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00726232

Purpose

To evaluate the safety and efficacy profile of different treatment regimens of INCB018424 administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group will be refractory to hydroxyurea or for whom hydroxyurea is contraindicated.

Condition	Intervention	Phase
Polycythemia Vera Essential Thrombocythemia	Drug: Ruxolitinib (INCB018424)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea

Resource links provided by NLM:

Genetics Home Reference related topics: essential thrombocythemia hemophilia MYH9-related disorder polycythemia vera

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Percent of subjects reaching confirmed clinical Partial Response (PR) or Complete Response (CR). [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
A confirmed response defined as a subject who met the criteria for PR or CR for a minimum of 2 continuous months. To have a confirmed CR, CR must have been observed for at least 2 months without an interim evaluation of < CR. Similarly a PR must have been observed at 2 time points without an interim evaluation of < PR.

Secondary Outcome Measures:

Evaluation of response rates as measured by laboratory values, systemic symptoms and absence of palpable spleen [ Time Frame: Measured from baseline through follow-up (On a three month basis) ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ruxolitinib (INB018424) 10 mg BID	Drug: Ruxolitinib (INCB018424) Treatment Arm 1 - Ruxolitinib 10mg BID
Experimental: Ruxolitinib (INCB018424) 25 mg BID	Drug: Ruxolitinib (INCB018424) Treatment Arm 2 - 25mg BID
Experimental: Ruxolitinib (INCB018424) 50 mg QD	Drug: Ruxolitinib (INCB018424) Treatment Arm 3 - 50mg QD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
Patient meets baseline clinical lab parameters

Exclusion Criteria:

Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years
Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
Clinically significant cardiac disease (NYHA Class III or IV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726232

Locations

United States, California

Beverly Hills, California, United States
United States, Texas

Houston, Texas, United States, 77030
Italy

Bergamo, Italy

Firenze, Italy

Pavia, Italy

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Edward Bradley, MD

Incyte Corporation

More Information

No publications provided

Responsible Party:	Pamela Murphy, VP Communications & IR, Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00726232 History of Changes
Other Study ID Numbers:	INCB 18424-256
Study First Received:	July 29, 2008
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health

Additional relevant MeSH terms:

Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Hematologic Diseases

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

ClinicalTrials.gov processed this record on February 12, 2012