A Phase 1, 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
- Conditions
- Prostate Cancer
- Registration Number
- JPRN-jRCT2080221560
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- Not specified
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 50ng/dL or less
- World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method