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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
Adults with untreated Acute Myeloid Leukemia who are not considered candidates for intensive remission induction using study drug SGI-110
| Sponsor: | Astex |
| Enrolling: | Male and Female Patients |
| Study Length: | 3 Years |
| IRB Number: | AAAP0470 |
| U.S. Govt. ID: | NCT02348489 |
| Contact: | Sarah Denoble: 212-342-3884 / sd2951@cumc.columbia.edu |
Additional Study Information:
The purpose of the study is to test how effective and safe the study drug SGI-110 is compared with current standard treatment for AML. The study drug, SGI-110, is changed in the body into a compound called decitabine. Decitabine is an approved drug in the US for treatment of patients with myelodysplastic syndrome (MDS) and in Europe for treatment of patients with acute myeloid leukemia (AML). Decitabine may block the growth of cancer cells. The study drug SGI-110 may have effects that differ from decitabine. The study drug SGI-110 will be given by a subcutaneous injection (under the skin).
This study is closed
