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

Sponsored by:	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: INCB018424	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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: hemophilia

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Hematological response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]
Symptomatic response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]
Splenomegaly response [ Time Frame: Individual timepoints sustained for at least 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in PD markers (e.g. plasma cytokines) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Safety and tolerability assessed by monitoring adverse events [ Time Frame: Ongoing and end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	105
Study Start Date:	July 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: INCB018424 Treatment Arm 1 - 10mg BID
2: Experimental	Drug: INCB018424 Treatment Arm 2 - 25mg BID
3: Experimental	Drug: 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

Pavia, Italy

Firenze, Italy

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Edward Bradley, MD

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pamela Murphy, VP Communications & IR )
Study ID Numbers:	INCB 18424-256
Study First Received:	July 29, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00726232 History of Changes
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health

Study placed in the following topic categories:

Polycythemia
Polycythemia Vera
Hydroxyurea
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Myeloproliferative Disorders
Hemostatic Disorders

Thrombocytopathy
Hemorrhagic Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Hemorrhagic Thrombocythemia
Essential Thrombocytosis
Bone Marrow Diseases

Additional relevant MeSH terms:

Polycythemia Vera
Polycythemia
Hemorrhagic Disorders
Hematologic Diseases
Blood Platelet Disorders

Blood Coagulation Disorders
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Hemorrhagic
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009