Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function

Inclusion Criteria:

* Diagnosis of one of the following:

  * MDS according to the French-American-British (FAB) classification system: refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), or chronic myelomonocytic leukemia (CMML); or
  * Acute myelogenous leukemia (AML) in remission,
  * Malignant solid tumor,
  * Multiple myeloma (MM),
  * Non-Hodgkin lymphoma (NHL), or
  * Hodgkin lymphoma (HD)
* Patients with a history of treated brain metastases should be clinically stable for greater than 4 weeks prior to signing the informed consent form and off glucocorticoid therapy for central nervous system (CNS) edema for at least 4 weeks
* Be capable of giving informed consent
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Have a life expectancy ≥ 3 months
* Have stable renal function for at least 2 months
* Have average calculated creatinine clearance of:

  * \>80 mL/min/1.73m\^2 for Cohorts 1, 2, 3, and 4
  * \<30 mL/min/1.73m\^2 for Cohort 5 - Severe renal impairment,
  * 50-80 mL/min/1.73m\^2 for Cohort 6 - Mild renal impairment,
  * 30 to \<50 mL/min/1.73m\^2 for Cohort 7 - Moderate renal impairment
* Have organ and marrow function at the screening and pre-dose visits as defined below:

  * Hemoglobin ≥8 g/dL,
  * Absolute neutrophil count ≥0.75 x 10\^3/µL,
  * Platelets ≥30 x 10\^3/µL,
  * Total bilirubin ≤1.5 times the upper limit of normal (ULN),
  * Aspartate aminotransferase (AST) ≤2 times the ULN, and
  * Alanine transaminase (ALT) ≤2 times the ULN;
* Have a 12-lead electrocardiogram (ECG) that is not clinically significant, as determined by the Investigator, at screening
* Have serum bicarbonate:

  * 20 mEq/L for patients with normal renal function (cohorts 1, 2, 3 and 4),
  * 16 mEq/L for patients with impaired renal function (cohorts 5, 6 and 7)
* Women of childbearing potential may participate, providing are not pregnant and agree to use at least 2 effective contraceptive methods throughout the study
* Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and to avoid fathering a child for 6 months following the date of the last dose of study medication
* Be a nonsmoker or must not have smoked for at least 30 days before the screening visit and agree to abstain from smoking during study participation

Exclusion Criteria:

* Women who are pregnant or nursing;
* Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to signing informed consent
* Have been treated with an investigational agent within 4 weeks prior to signing the informed consent form
* Have ongoing clinically significant adverse event(s) due to chemotherapy, radiotherapy or investigational agents administered more than 4 weeks prior to signing the informed consent as determined by the Investigator
* Have known or suspected hypersensitivity to azacitidine or mannitol
* Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
* Have low blood pressure (supine blood pressure \<90/60 mmHg)
* Have human immunodeficiency virus (HIV), or active hepatitis virus B or C
* Have advanced malignant hepatic tumors
* Have end stage renal disease requiring dialysis