Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

Summary

This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

Conditions

• Advanced Solid Malignancy
• Safety and Tolerability
• Pharmacokinetics
• Pharmacodynamics
• Tumour Response
• Advanced or Metastatic Breast Cancer
• Ovarian Cancer
• Cervical Cancer
• Endometrial Cancer
• PIK3CA
• AKT1
• PTEN
• ER Positive
• HER2 Positive

Interventions

DRUG

AZD5363

Patients will receive a single dose of AZD5363, administered orally, followed by a 3-7 day wash-out period. Patients will then commence with twice-daily dosing, administered orally, every day, to cessation of therapy.

DRUG

AZD5363

Patients will be given AZD5363 administered orally as a single dose, followed by a 3-7 day wash-out period. Patients will then receive AZD5363 twice daily on 6 or fewer days per weekly regimen, to cessation of therapy. Parts C,D: Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment, to cessation of therapy.

DRUG

AZD5363

Optional additional schedule. Patients will be given AZD5363 administered orally. Regimen to be determined in response to emerging clinical findings.

DRUG

AZD5363

Patients will receive oral AZD5363 twice daily (4 days on 3 days off treatment)combined with background therapy of fulvestrant at licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter.

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Gaia Schiavon, MSD · AstraZeneca

• Udai Banerji, MD, PhD · Institute of Cancer Research, United Kingdom

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

130 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-01

Primary Completion

2019-04-26

Completion

2024-12-03

Countries

• United States
• Canada
• Denmark
• France
• Italy
• Japan
• Netherlands
• Singapore
• Spain
• United Kingdom

Study Locations