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Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer

NCT03150056 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-08-10

Study results available
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Summary

This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).

Conditions

Interventions

DRUG

GSK525762

GSK525762 will be administered.

DRUG

Abiraterone

Abiraterone will be administered.

DRUG

Enzalutamide

Enzalutamide will be administered.

DRUG

Prednisone

Prednisone will be administered as a concomitant medication in combination with abiraterone

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2020-07-31
Completion
2021-06-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03150056 on ClinicalTrials.gov