Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Inclusion Criteria

• •Subjects must satisfy the following criteria to be enrolled in the study:
• •1. Age ≥ 18 years of age at the time of signing the informed consent document.
• •2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
• •3. Documented diagnosis of any of the following:
• •1. Myelodysplastic Syndrome (MDS) according to the World Health Organization (WHO) 2008 classification
• •2. Acute myeloid leukemia (AML)
• •3. Multiple myeloma (MM), limited to those patients for whom standard curative or palliative treatments do not exist or are no longer effective
• •4. Non-Hodgkin's lymphoma (NHL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective,
• •5. Hodgkin's lymphoma (HL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective
• •6. Metastatic or inoperable solid tumors\* (except gastrointestinal tumors or tumors that originated or metastasized to the liver) for which no standard treatment exists, or have progressed or recurred following prior therapy.
• •* Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.
• •4. Patients with a history of treated brain metastases should be clinically stable for ≥ 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system (CNS) edema is permitted if ≤ 20 mg of prednisolone (or equivalent).
• •5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •6. Have a life expectancy of ≥ 3 months.
• •7. Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by:
• •1. Serum creatinine \< 2.5 x the upper limit of normal (ULN)
• •2. An average calculated creatinine clearance \> 30 mL/min/1.73 m\^2
• •8. Have organ and marrow function at the screening and pre-dose visits as defined by:
• •1. Hemoglobin ≥ 8 g/dL
• •2. Absolute neutrophil count (ANC) ≥ 0.75 x 10\^3/uL without treatment with a myeloid growth factor within 3 days prior to first dose of IP
• •3. Platelets ≥ 30 x 10\^3/uL
• •4. Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN)
• •5. Aspartate aminotransferase (AST) ≤ 2 x ULN
• •6. Alanine aminotransferase (ALT) ≤ 2 x ULN
• •9. Have a 12-lead Electrocardiogram (ECG) that is not clinically significant at screening, as determined by the investigator
• •10. Females of childbearing potential (FCBP) may participate, providing the subject meets the following conditions:
• •* Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) or agree to practice true abstinence throughout the study, and for 3 months following the last dose of IP; and
• •* Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL); (Note that the screening serum pregnancy test can be used as the test prior to starting IP in the pharmacokinetics phase if it is performed within the 72-hour timeframe), and
• •* Negative serum or urine pregnancy test (investigator's discretion; sensitivity of at least 25 mIU/mL) within 72 hours prior to starting IP in the extension phase. (Note: subjects must have negative serum or urine pregnancy test prior to dosing on Day 1 of each treatment cycle in the extension phase.)
• •11. Male subjects must:
• •a. Practice true abstinence\* or agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study for at least 3 months following the last dose of IP.
• •\* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. \[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
• •12. Able to adhere to the study visit schedule and other protocol requirements.