RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis

Exclusion Criteria20

• Each participant must not meet any of the following:
• Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%.
• Prior history of hematopoietic stem cell transplant.
• Participation in any other study in which receipt of an investigational new drug occurred within 4 weeks prior to Cycle 1 Day 1.
• Active known second malignancy with the exception of any of the following:
• Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
• Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years
• Low-risk prostate cancer with a Gleason score <7 and a prostate-specific antigen (PSA) level <10 ng/mL
• Any other cancer from which the participant has been disease-free for ≥3 years.
• Known or suspected allergy to RVU120 or RUX.
• Impairment of gastrointestinal function or gastrointestinal disease
• Major surgical procedure or significant traumatic injury within 28 days Placement of a vascular access device or minor surgery is permitted within 14 days before Cycle 1 Day 1 (provided that the wound has healed).
• Ongoing systemic infection requiring antibiotic, antiviral, or antifungal treatment. Note: prophylactic treatment is allowed.
• Significant cardiac dysfunction defined as myocardial infarction within 12 months of Cycle 1 Day 1, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina (Section 17), or left ventricular ejection fraction (LVEF) <40% as per echocardiography or multiple gated acquisition (MUGA) scan.
• Taking any medications, herbal supplements, or other substances (including smoking) that are known to be strong inhibitors or moderate/strong inducers or sensitive substrates of CYP1A2, within less than 5 half-lives prior to Cycle 1 Day 1.
• History of ventricular arrhythmia, or QTc ≥470 millisecond (Bazett's formula).
• Known active human immunodeficiency virus (HIV) infection
• Current active liver disease from any cause
• Pregnant or lactating females.
• Any other prior or current medical or psychiatric condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the Investigator's opinion, could jeopardize participant safety or interfere with the objectives of the study.