Completed

PYRUSAZD5363 Monotherapy for Metastatic Castrate-Resistant Prostate Cancer: Safety, Tolerability, and Anti-Tumour Activity Assessment

Study Aim

This phase 1 study aims to evaluate the safety, tolerability, and anti-tumour activity of AZD5363 monotherapy in individuals with metastatic castrate-resistant prostate cancer, by measuring changes in prostate-specific antigen (PSA), circulating tumour cells (CTC), malignant soft tissue response rate, and metastatic bone disease status.

What is being tested

Intermittent dosing of AZD5363

+ Intermittent dosing of AZD5363

Drug

Who is being recruted

Urogenital Diseases+11

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Screening Study

Phase 1

Interventional

Study Start: November 2012

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: June 19, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity, Safety, Tolerability, and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (PYRUS)

NCT01692262

Principal SponsorAstraZeneca

Last updated: June 19, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SitePathologic ProcessesProstatic DiseasesPathological Conditions, Signs and SymptomsUrogenital NeoplasmsDisease AttributesMale Urogenital DiseasesProstatic NeoplasmsDisease Progression

Criteria

6 inclusion criteria required to participate

Documented evidence of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features for which no standard therapy is currently considered appropriate

Males aged 18 years and older

Part A: Patients must have received prior docetaxel-based chemotherapy for mCRPC and have a Circulating Tumour Cell score of 5

Show More Criteria

5 exclusion criteria prevent from participating

Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus

Any prior exposure to agents which inhibit AKT as the primary pharmacological activity

Clinically significant abnormalities of glucose metabolism

Major surgery within the previous 4 weeks

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Recruitment suspended and will not be re-opened. See intervention description below.

Group II

Experimental

Recruitment complete. See intervention description below.

Group III

Experimental

This part of the study will not be conducted following a review of data from Part A. See intervention description below.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Research Site

Sarasota, United StatesOpen Research Site in Google Maps

Research Site

Boston, United States

Research Site

Ann Arbor, United States

Research Site

Hackensack, United States

Completed8 Study Centers