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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3514 | Experimental | Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glen Clack, MD | AstraZeneca | Study Director |
| Takefumi Sato, MD | Kitasato University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sagamihara | Kanagawa | Japan | |||
| Research Site |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D055534 | Bulbo-Spinal Atrophy, X-Linked |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C583656 | AZD3514 |
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| 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
| 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 |
| Sunto-gun |
| Shizuoka |
| Japan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |