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| ID | Type | Description | Link |
|---|---|---|---|
| GU86 |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Group 1 Intermittent | Experimental | Recruitment suspended and will not be re-opened. See intervention description below. |
|
| Part A Group 2 Intermittent | Experimental | Recruitment complete. See intervention description below. |
|
| Part B | Experimental | This part of the study will not be conducted following a review of data from Part A. See intervention description below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent dosing of AZD5363 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Anti-tumour activity by measurement of changes in circulating prostate-specific antigen (PSA) | PSA measured from baseline for every 4 weeks. Primary assessment is at 12 weeks | |
| Parts A and B: Anti-tumour activity by measurement of changes in circulating tumour cells (CTC) | CTC measured from baseline for every 4 weeks to week 12 (primary assessment) then measured every 12 weeks | |
| Parts A and B: Anti-tumour activity by measurement of malignant soft tissue response rate | Tumour assessments by RECIST v1.1 every 12 weeks from baseline up to disease progression or withdrawal of consent | |
| Parts A and B: Anti-tumour activity by measurement of metastatic bone disease status | Bone lesion assessments by bone scan (PCWG2) criteria every 12 weeks from baseline up to disease progression or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Safety and tolerability of AZD5363 in terms of adverse events, serious adverse events (including death) and safety measures: ECG, ECHO/MUGA, physical examination, pulse, blood pressure, weight and laboratory variables | Routine safety assessments, throughout the period that patients receive AZD5363 up to 28 days following discontinuation of study treatment. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Stockman, MBCHB, PHD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sarasota | Florida | United States | |||
| Research Site |
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| Intermittent dosing of AZD5363 | 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. |
|
| Intermittent dosing of AZD5363 | 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. |
|
| Parts A and B: AZD5363 PK: time to maximum plasma concentration, terminal rate constant,terminal half life, area under plasma concentration time curve, plasma clearance & volume of distribution |
| Multiple AZD5363 PK blood sample assessments.AZD5363 plasma concentration blood samples will be taken on Day 1(pre-dose,2,4,8 hours post-dose);D2(pre-dose);D8(continous) or D11(intermittent) (pre-dose and at 2,4,and 8 hours post-dose);D15,Cyc |
| Parts A and B: Plasma concentrations of pharmacodynamic (PD) biomarker | Multiple PD blood sample assessments.PD blood samples will be taken on the same schedule as PK sample and then Day 1 of every 12 weeks thereafter, and at the discontinuation visit |
| Parts A and B: Progression-free survival (PFS) | Tumour assessments by RECIST v1.1 every 12 weeks from baseline up to disease progression or withdrawal of consent. |
| Parts A and B: Quality of life (QoL) | EORTC QLQ-C15-PAL, EORTC QLQ-PR25, and EORTC QLQ-BM22 Questionnaires | QOL will be documented from date of randomization and for 12 weeks. |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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