A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis
NCT ID: NCT03144687
Last Updated: 2022-06-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2018-01-26
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
NCT04629508
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
NCT06034002
Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
NCT00509899
A Phase 2 Study of INCB57643 (BET Inhibitor) in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis
NCT06619522
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
NCT04640025
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of the itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been \< 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
Itacitinib
Itacitinib self-administered orally once daily .
Ruxolitinib
Ruxolitinib self-administered orally at the stable dose of \< 20 mg daily established before entering the study.
Cohort B
Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
Itacitinib
Itacitinib self-administered orally once daily .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Itacitinib
Itacitinib self-administered orally once daily .
Ruxolitinib
Ruxolitinib self-administered orally at the stable dose of \< 20 mg daily established before entering the study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
•Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit.
Cohort B only
•Must have had initial reduction in spleen on ruxolitinib treatment:
* Followed by documented evidence of progression in spleen length or volume OR
* Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume.
All participants
* Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis according to revised World Health Organization 2016 criteria.
* Must have palpable spleen of greater than or equal to (≥) 5 centimeter (cm) below the left subcostal margin on physical examination at the screening visit.
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
* Screening bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24.
* Life expectancy of at least 24 weeks.
* Willingness to avoid pregnancy or fathering children
Exclusion Criteria
* Previous treatment with itacitinib or Janus kinase (JAK1) inhibitors (JAK1/JAK2 inhibitor ruxolitinib is permitted).
* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
* Recent history of inadequate bone marrow reserve as demonstrated by protocol-defined criteria.
* Inadequate liver function at screening and baseline visits as demonstrated by protocol-defined criteria.
* Inadequate renal function at screening and baseline visits as demonstrated by protocol-defined criteria.
* Active bacterial, fungal, parasitic, or viral infection that requires therapy.
* Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable. Participants cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibodies. Participants who have positive anti-HBs as the only evidence of prior exposure may participate in the study provided that there is both 1) no known history of HBV infection and 2) verified receipt of hepatitis B vaccine.
* Known human immunodeficiency virus infection.
* Clinically significant or uncontrolled cardiac disease.
* Active invasive malignancy 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. Participants with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery may be enrolled as long as they have a reasonable expectation to have been cured with the treatment modality received.
* Splenic irradiation within 6 months before receiving the first dose of itacitinib.
* Use of any prohibited concomitant medications.
* Active alcohol or drug addiction that would interfere with their ability to comply with the study requirements.
* Use of any potent/strong cytochrome P450 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of itacitinib or anticipated during the study.
* Use of concomitant treatment of fluconazole at a dose \> 200 mg (for ruxolitinib participants treated in Cohort A only).
* Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
* Currently breastfeeding or pregnant.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Langmuir
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Oncology Associates
Tempe, Arizona, United States
UC Irvine Medical Center
Orange, California, United States
Anschutz Cancer Pavilion - University Of Colorado
Aurora, Colorado, United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Providence Cancer Center
Southfield, Michigan, United States
Nebraska Cancer Specialist
Omaha, Nebraska, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Consultants in Medical Oncology and Hematology, PC
Broomall, Pennsylvania, United States
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Ordensklinikum Linz GmbH, Servicestelle für Studien
Linz, , Austria
Paracelsus Medical University Salzburg
Salzburg, , Austria
Hanusch Hospital
Vienna, , Austria
VU Medical Center
Amsterdam, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
UMC Utrecht Department of Hematology
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-005109-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 39110-209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.