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Combination Study of AZD5069 and Enzalutamide.

NCT03177187 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-26

No results posted yet for this study

Summary

ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

AZD5069

10mg and 40mg plain, beige, film-coated tablets packaged in bottles

DRUG

Enzalutamide 40 MG

Enzalutamide is presented in 40mg white to off white capsules or tablets. The capsules/tablets are provided in a cardboard wallet incorporating a PVC/PCTFE/aluminium blister which holds 28 soft capsules/tablets. Each carton contains 4 wallets (112 soft capsules/tablets). Or tablets in bottles (120 per bottle).

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Prostate Cancer UK

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Johann De Bono, MD · National Health Service, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2022-09-15
Completion
2022-11-16

Countries

  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT03177187 on ClinicalTrials.gov