At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 31 enrolled
Drug / intervention
azacitidinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating azacitidine for MDS and 5 related conditions. Completed, enrolled 31 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS, AML, Solid Tumors, Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartNov 2008
Primary CompletionJul 2012
TodayJul 2026
First PostedApr 4, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.2 years ago
Interventions
azacitidinedrug