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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Metastatic Castrate-Resistant Prostate Cancer (mCRPC),, Efficacy,, Safety and Tolerability,, Pharmacokinetics,, Pharmacodynamics,, Tumour Response.

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Trial Information

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)


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)


Inclusion Criteria:



- Provision of informed consent

- Males aged 18 years and older

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

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

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

- Part B: Patients must have progressed before receiving any chemotherapy for mCRPC

Exclusion Criteria:

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

- 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

- Spinal cord compression or brain metastases unless asymptomatic, treated, and stable
and not requiring steroids

- Clinically significant abnormalities of glucose metabolism

- Major surgery within the previous 4 weeks

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Parts A and B: Anti-tumour activity by measurement of changes in circulating prostate-specific antigen (PSA)

Outcome Time Frame:

PSA measured from beasline for every 4 weeks. Primary assesment is at 12 weeks

Safety Issue:

No

Principal Investigator

Paul Stockman, MBCHB, PHD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D3610C00003

NCT ID:

NCT01692262

Start Date:

October 2012

Completion Date:

August 2014

Related Keywords:

  • Metastatic Castrate-Resistant Prostate Cancer (mCRPC),
  • Efficacy,
  • Safety and Tolerability,
  • Pharmacokinetics,
  • Pharmacodynamics,
  • Tumour Response.
  • Metastatic Castrate-Resistant Prostate Cancer (mCRPC),
  • adenocarcinoma of the prostate,
  • prostate cancer,
  • progressive disease,
  • advanced disease.
  • Prostatic Neoplasms

Name

Location

Research SiteBattle Kreek, Michigan  
Research SiteBelleville, New Jersey  
Reserach SiteSarasota, Florida  
Reserach SiteBoston, Massachusetts  
Reserach SiteNashville, Tennessee