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Intermittent dosing of AZD5363

Phase 1

Metastatic Castrate-Resistant Prostate Cancer (mCRPC), | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 19, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01692262Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.PHASE1 COMPLETED 59 — — Nov 1, 2012Jun 1, 2014Jun 19, 20148 United States, United Kingdom
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Study Endpoints
Primary Endpoints
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.
Secondary Endpoints
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.
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSCREENING
Treatment Arms
ArmTypeDescription
Part A Group 1 IntermittentEXPERIMENTALRecruitment suspended and will not be re-opened. See intervention description below.
Part A Group 2 IntermittentEXPERIMENTALRecruitment complete. See intervention description below.
Part BEXPERIMENTALThis part of the study will not be conducted following a review of data from Part A. See intervention description below.
Interventions
NameTypeDescription
Intermittent dosing of AZD5363DRUGIntermittent 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites8

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 Meta...

Countries:United StatesUnited Kingdom
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