Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

• Status: Completed
• Trial end date: 2016-04-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• 18 years or older

• Diagnosis of MDS or CMML

• Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective

• ECOG Performance Status 0-2

• Use of acceptable birth control

• Standard safety inclusion for serum creatinine, AST, ALT, bilirubin

• Serum bicarbonate greater than or equal to 20 mEq/L

• Platelet count greater than or equal to 25,000/uL

• Hemoglobin greater than or equal to 500/uL

• Signed informed consent

Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia

• Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1

• Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment

• Hypersensitivity to azacitidine or mannitol

• Active, uncontrolled infection

• Presence of GI disease, malignant tumors or other conditions known to interfere with ADME

• Known or active HIV, viral hepatitis B or C

• Breastfeeding or pregnant females

• Current or uncontrolled cardiac disease