SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Phase 3 Completed 815 enrolled Astex Pharmaceuticals, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2015-03-19
Primary completion: 2018-05-31
Completion: 2019-06-17

Publications

Fenaux P, Gobbi M, Kropf PL, Issa JJ, Roboz GJ, Mayer J, Krauter J, Robak T, Kantarjian H, Novak J, Jedrzejczak WW, Thomas X, Ojeda-Uribe M, Miyazaki Y, Min YH, Yeh SP, Brandwein J, Gercheva-Kyuchukova L, Demeter J, Griffiths E, Yee K, Dohner K, Hao Y, Keer H, Azab M, Dohner H. Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study. Blood Adv. 2023 Sep 12;7(17):5027-5037. doi: 10.1182/bloodadvances.2023010179.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azacitidine	Other / unclassified	75 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	20 mg	Subcutaneous
Comparator	Decitabine	Small molecule	20 mg/m2	Intravenous
Subject	Guadecitabine	Oligonucleotide (other)	60 mg/m2	Subcutaneous

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Summary

Timeline

Publications

Drugs

Indications