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Dose-Finding Study of Afuresertib Administered in Combination With Either Enzalutamide or Aibraterone

NCT02380313 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-10-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Afuresertib

White of off-white round immediate release tablet for oral administration with unit dose strength of 50 mg and 75 mg to achieve the dosage level of 100 mg, 125 mg, 150 mg or 200 mg once daily.

DRUG

Enzalutamide

Opaque white to off-white capsule for oral administration with unit dose strength of 40mg to achieve dose level of 160 mg once daily.

DRUG

Abiraterone

White to off-white tablet for oral administration with unit dose strength 250 mg to achieve dose level of 1000 mg once daily.

DRUG

Prednisone

Continuous twice daily co administration of prednisone 5 mg as per labelled recommendation from United State Prescribing Information.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02380313 on ClinicalTrials.gov