drugset / Trial / NCT02177682
Study of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |