An Open Label Prostate Cancer Study in Japanese Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: AZD3514

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer	Number of participants with adverse events	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514	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)	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	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	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.
To obtain an preliminary assessment of the anti-tumour activity of AZD3514		Every 12 weeks
To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)		Day 8, 15, 29 and every 4 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Glen Clack, MD, AstraZeneca; Principal Investigator: Takefumi Sato, MD, Kitasato University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Prostate cancer; Japanese; Phase 1; Metastatic; Androgen receptor; Castration resistant; Down regulation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: D3760C00003