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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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221560
Enrollment
Unknown
Registered
2011-09-02
Start date
2011-09-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

investigational material(s) Generic name etc : AZD3514 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026