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A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02718300
First received: March 21, 2016
Last updated: July 27, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.

Condition Intervention Phase
Myelofibrosis Drug: INCB050465 Drug: Ruxolitinib Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 28 ]
  • Part 2: Change From Baseline in Spleen Volume at Week 12 as measured by MRI or CT scan [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures:
  • Number of subjects with adverse events (AEs) and changes in vital signs, ECGs, and laboratory parameters [ Time Frame: Screening through up to 30 days after last dose of study drug, up to 25 months ]
  • Change in total symptom score as measured by patient-reported myelofibrosis symptoms [ Time Frame: Baseline through Week 12 or Week 24 ]
  • Change From Baseline in Spleen Volume at Week 24 as measured by MRI or CT scan [ Time Frame: Baseline to Week 24 ]

Estimated Enrollment: 78
Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Ruxolitinib + INCB050465
Initial cohort dose of INCB050465 added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
Drug: INCB050465
Up to 3 oral once a day (QD) doses of INCB050465. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
Drug: Ruxolitinib
The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of INCB050465.
Other Name: Jakafi®
Experimental: Part 2: Ruxolitinib + INCB050465
Part 2 will compare 2 doses of INCB050465
Drug: INCB050465
Two recommended oral QD doses of INCB050465. Once daily doses of INCB050465 will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
Drug: Ruxolitinib
The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of INCB050465.
Other Name: Jakafi®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
  • Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

  • Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
  • Unwillingness to be transfused with blood components
  • Recent history of inadequate bone marrow reserve as demonstrated by the following:

    • Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
    • Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening
    • Subjects with peripheral blood blast count of > 10% at the screening or baseline hematology assessments
    • Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels
  • Inadequate liver function at screening as demonstrated by the following:

    • Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
    • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
  • Inadequate renal function at screening as demonstrated by creatinine clearance < 50 mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2
  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: NCT02718300

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates, LLC d.b.a Alabama Oncology Not yet recruiting
Birmingham, Alabama, United States, 35223
Contact: Study Coordinator    205-599-4929      
United States, California
City of Hope Medical Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Study Coordinator    626-256-4673      
Keck School of Medicine of USC Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Study Coordinator    323-865-3577      
The Regents of the University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Study Coordinator    310-794-0242      
United States, Florida
Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Study Coordinator    352-273-7832      
United States, Illinois
Rush University Medical Center-Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Study Coordinator    312-942-5157      
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-2084      
United States, Indiana
Indiana Blood & Marrow Transplantation, LLC Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Study Coordinator    317-528-5500      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Study Coordinator    646-317-5199      
United States, Kansas
The University of Kansas Medical Center Research Institute, Inc. Recruiting
Westwood, Kansas, United States, 66205
Contact: Study Coordinator    913-945-5793      
United States, Kentucky
Norton Hospitals, Inc. d.b.a. Norton Cancer Institute Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Study Coordinator    502-629-6068      
United States, Maryland
St. Agnes Hospital Recruiting
Baltimore, Maryland, United States, 21229
Contact: Study Coordinator    410-368-2966      
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Study Coordinator    617-724-1124      
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-362-8846      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Study Coordinator    551-996-3925      
Summit Medical Group Recruiting
Morristown, New Jersey, United States, 07960
Contact: Study Coordinator    973-476-1755      
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Study Coordinator    716-845-1205      
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Study Coordinator    212-241-4106      
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Study Coordinator    646-317-5199      
Memorial Sloan Kettering Cancer Center- MAIN Not yet recruiting
New York, New York, United States, 10065
Contact: Study Coordinator    646-888-1042      
Montefiore Medical Center by Agent Biomedical Research Assoc. of New York Not yet recruiting
The Bronx, New York, United States, 10467
Contact: Study Coordinator    718-920-4137      
United States, Ohio
Oncology/Hematology Care, Inc. and Oncology Hematology Care Clinical Trials, LLC Not yet recruiting
Cincinnati, Ohio, United States, 45242
Contact: Study Coordinator    313-731-2273      
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44106
Contact: Study Coordinator    216-445-9840      
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-346-0227      
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-794-4392      
Cancer Care Centers of South Texas Recruiting
Kerrville, Texas, United States, 78028
Contact: Study Coordinator    210-595-5300      
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    801-587-9178      
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Albert Assad, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02718300     History of Changes
Other Study ID Numbers: INCB 50465-201
Study First Received: March 21, 2016
Last Updated: July 27, 2017

Keywords provided by Incyte Corporation:
Primary myelofibrosis (PMF)
post-polycythemia vera myelofibrosis (PPV-MF)
post-essential thrombocythemia myelofibrosis (PET-MF)
myeloproliferative neoplasms (MPNs)
phosphoinositide 3-kinase (PI3K) inhibitor
Janus kinase (JAK) inhibitor

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 19, 2017