AKT Inhibitor in Oestrogen Positive Breast Cancer

NCT02077569 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-05-04

No results posted yet for this study

Summary

To compare the effect of four and a half days treatment of a range of doses of AZD5363 on selected markers of the AKT pathway and anti-proliferation compared with placebo in oestrogen receptor positive breast cancers.

To assess the tolerability of four and a half days treatment of AZD5363.

Conditions

Interventions

DRUG

AZD5363

Stage 1: AZD5363 480mg or placebo twice daily oral dosing for 4 and 1/2 days (9 doses) Stage 2: AZD5363 360mg or 240mg daily oral dosing for 4 and 1/2 days (9 doses)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • Cancer Research UK

    collaborator OTHER
  • National Cancer Research Network

    collaborator NETWORK
  • University of Nottingham

    lead OTHER

Principal Investigators

  • John FR Robertson, MD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-02-21
Completion
2017-02-21

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02077569 on ClinicalTrials.gov