An Open Label Prostate Cancer Study in Japanese Patients

NCT01351688 | Completed Phase 1

• 1 other identifier: D3760C00003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Phase 1; Metastatic; Castration resistant; Prostate cancer; Androgen receptor; Down regulation; Japanese

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514

  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

  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

Study Arms (1)

AZD3514

EXPERIMENTAL

Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)

Drug: AZD3514

Interventions

AZD3514 DRUG

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.

AZD3514

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Sagamihara, Kanagawa, Japan

Location

Research Site

Sunto-gun, Shizuoka, Japan

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis; Bulbo-Spinal Atrophy, X-Linked

Interventions

AZD3514

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Glen Clack, MD

  AstraZeneca

  STUDY DIRECTOR

• Takefumi Sato, MD

  Kitasato University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: May 11, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

JP (2)