Trials / Completed
CompletedNCT00761722
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
A Phase I, Dose-Ranging Study to Evaluate the Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously (SC) and as Different Oral Formulations in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma
- 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 compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Lymphoma
- Multiple Myeloma
- Leukemia, Myelomonocytic, Chronic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azacitidine | Arm 1: Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19. Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle. Arm 2: All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle. |
Timeline
- Start date
- 2008-08-12
- Primary completion
- 2016-04-06
- Completion
- 2016-04-07
- First posted
- 2008-09-29
- Last updated
- 2019-11-08
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00761722. Inclusion in this directory is not an endorsement.