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

Completed · Phase 1

Conditions studied: MDS, AML, Solid Tumors, Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Disease

In brief

The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations. The second is to determine the effect renal impairment has or does not have on the absorption of azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients with renal function impairment.

Key facts

Study ID

NCT00652626

Run by

Celgene

People needed

31

Starts

2008-11-01

Expected to finish

2012-07-01

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sutter East Bay Hospitals — Berkeley, California, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• MCG Cancer Center — Augusta, Georgia, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• University of Kentucky-Markey Cancer Center Clinical Research Organization — Lexington, Kentucky, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Mid Dakota Clinical P.C. - Cancer Treatment and Research Center — Bismarck, North Dakota, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Pharma Resource — East Providence, Rhode Island, United States
• Cancer Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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