An Open Label Study of INCB039110 Administered Orally in Patients With Myelofibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01633372
First received: June 26, 2012
Last updated: August 26, 2014
Last verified: August 2014
  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:


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 The Myelofibrosis Symptom Assessment Form (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
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110 100 mg
INCB039110 100 mg twice a day
Drug: INCB039110
Experimental: INCB039110 200 mg
INCB039110 200 mg twice a day
Drug: INCB039110
Experimental: INCB039110 300 mg
INCB039110 300 mg once a day
Drug: INCB039110
Experimental: INCB039110 400 mg
INCB039110 400 mg once a day
Drug: INCB039110
Experimental: INCB039110 600 mg
INCB039110 600 mg once a day
Drug: INCB039110

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, California
Los Angeles, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, New York
New York, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Albert Assad, 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: August 26, 2014
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
Blood Coagulation Disorders
Blood Platelet Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemorrhagic Disorders
Myeloproliferative Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014