Investigating safety, tolerability and efficacy of AZD5363 in prostate cancer. - PYRUS
Study identifier:D3610C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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)
Medical condition
Metastatic Castrate-Resistant Prostate Cancer (mCRPC),, Pharmacokinetics,
Phase
Phase 1
Healthy volunteers
No
Study drug
Intermittent dosing of AZD5363
Sex
Male
Actual Enrollment
59
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Nov 2012
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jun 2014
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Verification:
Verified 01 Jun 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A Group 1 Intermittent Recruitment suspended and will not be re-opened. See intervention description below. | Drug: 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. |
| Experimental: Part A Group 2 Intermittent Recruitment complete. See intervention description below. | 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. |
| Experimental: Part B This part of the study will not be conducted following a review of data from Part A. See intervention description below. | 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. |
Contacts
Investigators
Principal Investigator
Paul Stockman
AstraZeneca
