A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis (NCT05037760) | Clinical Trial Compass
RecruitingPhase 2
A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis
Australia135 participantsStarted 2021-12-16
Plain-language summary
The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
✓. In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
✓. Male or female greater than equal to (≥)18 years of age, at the time of signing informed consent.
✓. Eastern Cooperative Oncology Group (ECOG) performance score lesser than equal to (≤)2.
✓. Life expectancy ≥12 months per Investigator assessment.
✓. Confirmed diagnosis of primary myelofibrosis (PMF) (prefibrotic or overtly fibrotic) according to the 2016 World Health Organization (WHO) criteria, post-polycythemia vera myelofibrosis (PV MF), or post-essential thrombocythemia myelofibrosis (ET MF) according to the 2008 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.
✓. Anemia, defined as:
✓. Having received ≥6 units of RBC transfusion for Hgb ≤8.5 g/dL in the 12 weeks prior to the planned C1D1, including ≥1 unit of RBC transfusion in the 28 days prior to C1D1; or
Exclusion criteria
✕. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
What they're measuring
1
Part 1: Number of Participants with Adverse Events (AEs), Dose Limiting Toxicities (DLTs), Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From signing of the informed consent form (ICF) through 30 days after the last dose of study drug (approximately 8 years)
2
Part 2 and Long-Term Extension: Number of Participants with Adverse Events (AEs), Severe AEs and SAEs
Timeframe: From signing of the ICF through 30 days after the last dose of study drug, (approximately 8 years)
✕. New York Heart Association Class 3 or 4 heart failure
✕. QTcF (QT interval corrected by Fridericia's formula) \>500 milliseconds (msec) on the screening or C1D1 electrocardiogram (ECG; mean of 3 measurements)
✕. Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded)
✕. Acute myocardial infarction or unstable angina pectoris ≤6 months prior to C1D1
✕. Body mass index (BMI) ≥40 kilograms per meter square (kg/m\^2).
✕. Presence of uncontrolled hypertension, defined as systolic blood pressure ≥160 millimeters of mercury (mmHg) or diastolic blood pressure ≥100 mmHg despite adequate treatment.