Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD3514 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD3514
- description
- Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
- interventionNames
- Drug: AZD3514
Primary outcomes (1)
- measure
- To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
- timeFrame
- 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
- description
- Number of participants with adverse events
Secondary outcomes (4)
- measure
- To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available