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A Phase I Study of ARRY-614 in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes
|Myelodysplastic Syndrome (MDS)
- Primary Objective
- Determine the recommended Phase 2 schedule (once-daily [QD] or twice-daily [BID] dosing) and dose of ARRY-614 administered as a semi-solid suspension (formulated) capsule in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS)
- Secondary Objectives:
- Obtain preliminary estimates of efficacy of ARRY-614
- Explore potential markers for response in bone marrow and peripheral blood samples, as feasible
- Assess possible pharmacokinetics (PK)/safety, PK/pharmacodynamics (PD), PK/efficacy and PD/efficacy correlations
- Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- Male or female ≥ 18 years of age at time of signing consent.
- Confirmed MDS by bone marrow biopsy according to WHO or FAB criteria.
- Classification by the IPSS as low or intermediate-1 risk MDS according to cytogenetics, blood cytopenias and % bone marrow blasts within 6 weeks of the first dose of treatment in this study.
- Patients may have received prior therapies for MDS. Newly diagnosed and previously untreated cases are also eligible if they require treatment and are not eligible for or refuse other treatment options.
- Documented evidence of at least 1 of the following hematopoietic criteria for ≥ 12 weeks:
- a. Hemoglobin ≤ 11 g/dL and/or RBC transfusion dependence (defined as requiring ≥ 4 units of packed RBCs administered with a pretreatment hemoglobin value of ≤ 9 g/dL in the 8 weeks prior to first dose of treatment in this study).
- b. ANC ≤ 1.5 × 109/L.
- c. Platelet count ≤ 100 × 109/L or platelet transfusion dependence (defined as ≥ 1 platelet transfusion administered with a pretreatment platelet value of ≤ 20 × 109/L in the 8 weeks prior to first dose of treatment in this study).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Adequate liver function:
- a.Total bilirubin ≤ 1.5 × the upper limit of normal (ULN), unless presence of Gilbert’s Syndrome.
- b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Adequate renal function: Serum creatinine ≤ 2 mg/dL or a calculated creatinine clearance of ≥ 50 mL/min (using the Cockcroft and Gault method).
- Male patients and female patients of childbearing potential must agree to use an effective method of contraception per institutional standard.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Receiving any treatment for MDS other than transfusions or hematopoietic growth factors on study Day 1.
- Treatment with any of the following:
- a) Azacitidine or decitabine: within 2 weeks prior to first dose of study treatment.
- b) Chronic use (greater than 2 weeks) of greater than physiologic doses of PO, subcutaneous (SC) or intravenous (IV) corticosteroids (dose equivalent to more than 20 mg/day of prednisone): within 4 weeks prior to the first dose of study treatment.
- c) Immunomodulatory agent (e.g., lenalidomide): within 4 weeks prior to the first dose of study treatment.
- History of a bone marrow transplant.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis.
- Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
- Any severe concurrent disease or condition (including active systemic infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia) that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Patients with chronic myelomonocytic leukemia whose WBC count has been ≥ 13.0 x 10^9/L at any point during the 8 weeks prior to the first dose of study drug.
- Patients who require oral anticoagulants with coumarin derivates (e.g., warfarin, phenprocoumon), unless the patient is willing to allow for increased vigilance with respect to international normalized ratio (INR) testing per institutional monitoring practices.
- 12-lead ECG demonstrating a QTcF of ≥ 480 msec (mean of the triplicate ECG measurements) collected during Screening.
- Significant GI abnormalities, including an inability to take oral medication, requirement for intravenous (IV) alimentation, active peptic ulcer, or prior surgical procedures affecting absorption.
- Use of an investigational agent that is not expected to be cleared by the first dosing of study drug or that has demonstrated to have prolonged side effects. Patients should have recovered from the side effects to a Grade 0 or 1 (except alopecia).
- Pregnant or lactating females.
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