drugset / Trial / NCT01254890
Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome
Phase 1/2
Completed
60 enrolled
M.D. Anderson Cancer Center
Bayer · collabCelgene Corporation · collabOnyx Therapeutics, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.
Timeline
- Start
- 2011-01
- Primary completion
- 2015-03
- Completion
- 2015-03
Publications
- Ohanian M, Garcia-Manero G, Levis M, Jabbour E, Daver N, Borthakur G, Kadia T, Pierce S, Burger J, Richie MA, Patel K, Andreeff M, Estrov Z, Cortes J, Kantarjian H, Ravandi F. Sorafenib Combined with 5-azacytidine in Older Patients with Untreated FLT3-ITD Mutated Acute Myeloid Leukemia. Am J Hematol. 2018 Sep;93(9):1136-1141. doi: 10.1002/ajh.25198. Epub 2018 Aug 31.
- Ravandi F, Alattar ML, Grunwald MR, Rudek MA, Rajkhowa T, Richie MA, Pierce S, Daver N, Garcia-Manero G, Faderl S, Nazha A, Konopleva M, Borthakur G, Burger J, Kadia T, Dellasala S, Andreeff M, Cortes J, Kantarjian H, Levis M. Phase 2 study of azacytidine plus sorafenib in patients with acute myeloid leukemia and FLT-3 internal tandem duplication mutation. Blood. 2013 Jun 6;121(23):4655-62. doi: 10.1182/blood-2013-01-480228. Epub 2013 Apr 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |