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Intermittent dosing of AZD5363

Phase 1

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

Intermittent dosing of AZD5363 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Intermittent dosing of AZD5363 clinical trials

Intermittent dosing of AZD5363 · 1 trial · 6 indications

Phase 1 1
NCT01692262Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.Metastatic Castrate-Resistant Prostate Cancer (mCRPC),
COMPLETED59 Analytics
PHASE1COMPLETED
Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.
Metastatic Castrate-Resistant Prostate Cancer (mCRPC),
NCT0169226259
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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 to 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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Frequently asked questions about Intermittent dosing of AZD5363

What is intermittent dosing of AZD5363?

Intermittent dosing of AZD5363 refers to a schedule in which the small molecule AZD5363 is given in cycles with treatment breaks rather than continuously. AstraZeneca studied this approach in a Phase 1 trial in men with metastatic castrate-resistant prostate cancer, evaluating safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics.

What is intermittent dosing of AZD5363 used for in metastatic castrate-resistant prostate cancer?

Intermittent dosing of AZD5363 was studied for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). The Phase 1 trial enrolled 59 men aged 18 years and older in the United States and the United Kingdom, and assessed efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics and tumor response in this population.

Who is developing intermittent dosing of AZD5363?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD5363. The company sponsored the Phase 1 study of intermittent dosing of AZD5363 in metastatic castrate-resistant prostate cancer.

What phase is intermittent dosing of AZD5363 in?

Intermittent dosing of AZD5363 is in Phase 1 development. The single registered trial, NCT01692262, titled Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer, has completed. AZD5363 is an investigational small molecule and is not an approved therapy for metastatic castrate-resistant prostate cancer.

What clinical trials is intermittent dosing of AZD5363 in?

Intermittent dosing of AZD5363 has been evaluated in one clinical trial, NCT01692262, a completed Phase 1 study titled Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer. The trial enrolled 59 male participants aged 18 years and older across the United States and the United Kingdom and used a controlled design.

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