Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

Recruitment complete. See intervention description below.

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

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.

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.

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.

Paul Stockman, MBCHB, PHD

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.

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)

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

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)

EORTC QLQ-C15-PAL, EORTC QLQ-PR25, and EORTC QLQ-BM22 Questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.	NCT01692262	Metastatic Cast... Efficacy, Safety and Tole... Pharmacokinetic... Pharmacodynamic... Tumour Response...	Intermittent do... Intermittent do... Intermittent do...	18 Years -	AstraZeneca
Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.	NCT01692262	Metastatic Cast... Efficacy, Safety and Tole... Pharmacokinetic... Pharmacodynamic... Tumour Response...	Intermittent do... Intermittent do... Intermittent do...	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for pharmacodynamics,