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| ID | Type | Description | Link |
|---|---|---|---|
| KU36-37 |
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| Name | Class |
|---|---|
| KuDOS Pharmaceuticals Limited | INDUSTRY |
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Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2281 | Drug | 100mg Oral Dose |
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| Measure | Description | Time Frame |
|---|---|---|
| To characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours, assessed by blood, urine and faecal sampling | Various timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs. | ||
| To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Carmichael, BSc, MBChB, MD, FRCP | KuDOS Pharmaceuticals, Ltd | Study Director |
| Johann deBono, MD, FRCP, MSc PhD | Royal Marsden Hospital, Surrey, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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