An Open Label Prostate Cancer Study in Japanese Patients - Full Text View

Purpose

The primary aim of study is to gain an initial assessment of safety and tolerability of AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to Japanese patients with metastatic castration resistant prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: AZD3514	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD3514 in Japanese Patients With Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer [ Time Frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified ] [ Designated as safety issue: Yes ]
Number of participants with adverse events

Secondary Outcome Measures:

To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514 [ Time Frame: during the single dose period and the first 21 days of multiple dosing (ie, by study day 29) ] [ Designated as safety issue: Yes ]
A DLT is defined as any toxicity not attributable to the disease or disease-related processes under investigation and considered to be related to AZD3514 therapy during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)
To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses [ Time Frame: Multiple timepoints taken, begining at Day 1 and until 48 hrs after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. ] [ Designated as safety issue: No ]
To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses
- Cmax
- Cmax at steady state (Cmax, ss)
- time to maximum concentration (tmax)
- tmax at steady state (tmax, ss)
- terminal elimination rate constant (λz)
- (AUC(0-t))
- total clearance and terminal phase (Vz) of AZD3514
To obtain an preliminary assessment of the anti-tumour activity of AZD3514 [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA) [ Time Frame: Day 8, 15, 29 and every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2011
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD3514 Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)	Drug: AZD3514 Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males aged 20 years or older.
Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate
Documented evidence of metastatic prostate cancer
Serum testosterone concentration ≤50 ng/dL
World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Exclusion Criteria:

History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514
Inadequate bone marrow reserve or organ function
Concurrent or recent treatment with certain medications or medical procedures
Any medically important factors identified from electrocardiogram (ECG) measurements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351688

Locations

Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Sunto-gun, Shizuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Glen Clack, MD	AstraZeneca
Principal Investigator:	Takefumi Sato, MD	Kitasato University

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01351688 History of Changes
Other Study ID Numbers:	D3760C00003
Study First Received:	April 11, 2011
Last Updated:	May 25, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Phase 1
Metastatic
Castration resistant
Prostate cancer

Androgen receptor
Down regulation
Japanese

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013