Myelofibrosis Clinical Trial
Official title:
A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
Verified date | August 2023 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Status | Completed |
Enrollment | 4 |
Est. completion date | August 24, 2023 |
Est. primary completion date | August 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria. - At least Intermediate 1 risk MF according to the DIPSS. - Prior treatment with ruxolitinib and/or fedratinib monotherapy - Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF. - Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume = 450 cm3 on imaging assessed during screening. - Allogeneic stem cell transplant not planned. - Platelet is greater than or equal to 50 × 109/L at screening. - Ability to comprehend and willingness to sign a written ICF for the study. - Willingness to avoid pregnancy or fathering children. Exclusion Criteria: - Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib - Record of = 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening - For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents - Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1 - Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib - Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement - Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study - ECOG performance status = 3 - Life expectancy less than 24 weeks - Not willing to receive RBC or platelet transfusions - Participants with laboratory values at screening outside of protocol defined ranges - Significant concurrent, uncontrolled medical condition - Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor - History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful - Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. - Evidence of HBV or HCV infection or risk of reactivation - Known HIV infection. |
Country | Name | City | State |
---|---|---|---|
Austria | Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord | Linz | |
Belgium | Cliniques Universitaires Ucl Saint-Luc | Brussels | |
Belgium | Jessa Ziekenhuis | Hasselt | |
Belgium | AZ DELTA | Roeselare | |
Belgium | Chu Ucl Namur University Hospital Mont-Godinne | Yvoir | |
Germany | Universitaetsmedizin Greifswald | Greifswald | |
Germany | Universitatsklinikum Halle (Saale) | Halle (saale) | |
Italy | Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele | Milan | |
Italy | Aou San Giovanni Di Dio E Ruggi | Salerno | |
Italy | Treviso Hospital | Treviso | |
Poland | Pratia Hematologia Katowice | Katowice | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitari I Politecnic La Fe | Valencia | |
United States | Rcca Md, Llc | Bethesda | Maryland |
United States | New Jersey Hematology Oncology Associates Llc | Brick | New Jersey |
United States | Texas Oncology - Baylor Sammons Cancer Center | Dallas | Texas |
United States | Midamerica Cancer Care | Kansas City | Missouri |
United States | Baptist Cancer Center | Memphis | Tennessee |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Tulane University | New Orleans | Louisiana |
United States | Renovatio Clinical Consultants Llc | Spring | Texas |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Austria, Belgium, Germany, Italy, Poland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1 : Treatment Emergent Adverse Events (TEAE'S) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment. | 24 Weeks | |
Primary | Part 2 : Spleen Volume Reduction by MRI/CT Scan | Defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35 percent when compared with baseline. | 24 weeks | |
Primary | Part 2 : Spleen Volume Reduction | Defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35% when compared with baseline. | 24 weeks | |
Secondary | Part 2 : Treatment Emergent Adverse Events (TEAE'S) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment. | 13 months | |
Secondary | Part 2 : Improvement in Total Symptom Score (TSS) | Defined as the proportion of participants who achieve at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib IR (baseline). | 24 Weeks | |
Secondary | Part 2 : Improvement in quality of life. | Defined as the mean change in the 5 multi-item functional scale scores and the multi-item global health status scale score (EORTC QLQ-C30). | 24 weeks | |
Secondary | Part 2 : Improvement in Patient Global Impression of Change (PGIC) | Defined as percentage of participants who are categorized as improved | 24 Weeks |
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