Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.

Completed · Phase 1

Conditions studied: Metastatic Castrate-Resistant Prostate Cancer (mCRPC),, Efficacy,, Safety and Tolerability,, Pharmacokinetics,, Pharmacodynamics,, Tumour Response.

In brief

To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving chemotherapy (Part B). Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off). Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients on a dose and schedule selected from Part A.

Key facts

Study ID

NCT01692262

Run by

AstraZeneca

People needed

59

Starts

2012-11-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• Research Site — Sarasota, Florida, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Cardiff, Wales, United Kingdom
• Research Site — London, United Kingdom
• Research Site — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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