Trials / Completed
CompletedNCT02348489
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 815 (actual)
- Sponsor
- Astex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SGI-110 (guadecitabine) | Investigational medicinal product |
| DRUG | Treatment Choice | Choice of one: cytarabine, decitabine, or azacitidine |
Timeline
- Start date
- 2015-03-19
- Primary completion
- 2018-05-31
- Completion
- 2019-06-17
- First posted
- 2015-01-28
- Last updated
- 2024-08-27
- Results posted
- 2021-01-14
Locations
135 sites across 24 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Romania, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02348489. Inclusion in this directory is not an endorsement.