Trials / Completed
CompletedNCT01599325
Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Chinese Subjects With Higher-Risk Myelodysplastic Syndromes
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine | Subcutaneous administration of azacitidine 75 mg/m\^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason |
Timeline
- Start date
- 2012-07-24
- Primary completion
- 2015-01-29
- Completion
- 2018-03-13
- First posted
- 2012-05-16
- Last updated
- 2019-03-19
- Results posted
- 2016-02-29
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01599325. Inclusion in this directory is not an endorsement.