drugset / Trial / NCT02177682

Study of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients

NCT02177682

Phase 1 Terminated 9 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the subjects meet any study treatment withdrawal criteria including disease progression. A total of up to 24 subjects will be enrolled in the study.

Timeline

Start
2014-08-13
Primary completion
2017-02-09
Completion
2019-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Afuresertib Small molecule 125 mg Oral
Subject Afuresertib Small molecule 150 mg Oral
Subject Afuresertib Small molecule 175 mg Oral
Subject Afuresertib Small molecule 200 mg Oral