An Open Label Study of INCB039110 Administered Orally in Patients With Myelofibrosis - Full Text View

Purpose

This is a study of INCB039110 in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of INCB039110.

Condition	Intervention	Phase
Primary Myelofibrosis Post Polycythemia Vera Fibrosis Post Essential Thrombocythemia Myelofibrosis	Drug: INCB039110	Phase 2

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, Multiple Simon 2-Stage Study of INCB039110 Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified MFSAF v3.0 diary [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level [ Time Frame: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit. ] [ Designated as safety issue: No ]
Safety and tolerability of INCB039110 as measured by adverse events. [ Time Frame: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	125
Study Start Date:	April 2012
Estimated Study Completion Date:	January 2018
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INCB039110 100 mg twice a day	Drug: INCB039110
Experimental: INCB039110 200 mg twice a day	Drug: INCB039110
Experimental: INCB039110 300 mg once a day	Drug: INCB039110
Experimental: INCB039110 400 mg once a day	Drug: INCB039110
Experimental: INCB039110 600 mg once a day	Drug: INCB039110

Eligibility

Criteria

Inclusion Criteria:

Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
Subjects must have palpable spleen or history of splenectomy
Active symptoms at the screening visit

Exclusion Criteria:

Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.
Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633372

Contacts

Contact: Incyte Call Center

1-855-463-3463

Locations

United States, Alabama
	Recruiting
Birmingham, Alabama, United States
United States, Arizona
	Recruiting
Scottsdale, Arizona, United States
United States, California
	Recruiting
Los Angeles, California, United States
United States, Georgia
	Recruiting
Atlanta, Georgia, United States
United States, Maryland
	Recruiting
Baltimore, Maryland, United States
United States, Michigan
	Recruiting
Ann Arbor, Michigan, United States
United States, New York
	Recruiting
New York, New York, United States
United States, Oregon
	Not yet recruiting
Portland, Oregon, United States
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States
	Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
	Recruiting
Columbia, South Carolina, United States
United States, Tennessee
	Recruiting
Memphis, Tennessee, United States
	Recruiting
Nashville, Tennessee, United States
United States, Texas
	Recruiting
Houston, Texas, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Bijoyesh Mookerjee, MD

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT01633372 History of Changes
Other Study ID Numbers:	INCB 39110-230
Study First Received:	June 26, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Primary Myelofibrosis
PMF
Post Polycythemia Vera Fibrosis

PPV-MF
Post Essential Thrombocythemia Myelofibrosis
PET-MF

Additional relevant MeSH terms:

Primary Myelofibrosis
Fibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders

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

ClinicalTrials.gov processed this record on June 18, 2013