Dose-Finding Study of Afuresertib Administered in Combination With Either Enzalutamide or Aibraterone
Status:
Withdrawn
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
This study is being conducted to characterize the safety and recommended phase 2 dose (RP2D)
of combining afuresertib, independently with 2 approved drugs: enzalutamide (Xtandi®, "Xtandi
is a trademark of Astellas Pharma, Inc." ) and abiraterone (Zygita®, "Zytiga is a trademark
of Janssen Biotech, Inc."). The study will be conducted in two parts. Part 1, a dose
escalation phase, will establish RP2D of afuresertib when administered with enzalutamide or
abiraterone. Part 2, a dose expansion phase, will further evaluate long-term safety of the
combinations at the RP2Ds in additional subjects. Dose-finding cohorts will be studied in
parallel and will evaluate safety and pharmacokinetic to guide selection of the dose regimens
for further evaluation. Part 2 will begin once the RP2Ds have been established in Part 1.
Additional doses and/or schedules may be explored if warranted, based upon the
pharmacokinetic (PK) and pharmacodynamic (PD) assessments or emerging preclinical evidence.
Overall, approximately 60 chemotherapy-naïve subjects with mCRPC and who are receiving either
enzalutamide or abiraterone will be enrolled into the study.