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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Part A Group 1 Intermittent

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

Group Type EXPERIMENTAL

Intermittent dosing of AZD5363

Intervention Type DRUG

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Recruitment suspended and will not be re-opened.

Part A Group 2 Intermittent

Recruitment complete. See intervention description below.

Group Type EXPERIMENTAL

Intermittent dosing of AZD5363

Intervention Type DRUG

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue to study withdrawal. Recruitment complete.

Part B

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

Group Type EXPERIMENTAL

Intermittent dosing of AZD5363

Intervention Type DRUG

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue until study drug withdrawal. This part of the study will not be conducted.

Interventions

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Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Recruitment suspended and will not be re-opened.

Intervention Type DRUG

Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue to study withdrawal. Recruitment complete.

Intervention Type DRUG

Intermittent dosing of AZD5363

Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue until study drug withdrawal. This part of the study will not be conducted.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No