NCT00652626

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

A Phase 1, Open-Label, Multi-Center, Parallel Group Study to the Pharmacokinetics and Safety of Subcutaneous Azacitidine in Adult Cancer Patients With and Without Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• MDS
• AML
• Solid Tumors
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Hodgkin's Disease

Interventions

Type	Name	Description
DRUG	azacitidine

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-04-04
• Last updated: 2019-11-19
• Results posted: 2013-10-17

Locations

11 sites across 1 country: United States