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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001255-13 | EudraCT Number |
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This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted | Other | Olaparib capsules following no breakfast |
|
| Standard meal | Other | Olaparib capsules after standard breakfast |
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| High Fat | Other | Olaparib capsules after high fat breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | 400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Olaparib (Cmax and tmax) | Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax) | Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose |
| Pharmacokinetics of Olaparib (AUC0-t) | Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t) | Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose. |
| Pharmacokinetics of Olaparib (AUC) | Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC) | Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose |
| Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½) | Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½) | Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety monitoring of Olaparib | Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anitra Fielding | AstraZeneca Senior Research Physician | Study Director |
| Christian Rolfo | UZ Antwerpen | Principal Investigator |
| Wendy Bannister | AstraZeneca Study Statistician | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edegem | 2650 | Belgium | |||
| Research Site |
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| Label | URL |
|---|---|
| D081AC00001\_CSR\_Synopsis | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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| Dietary Fasted | Other | Allocated breakfast prior to dosing with 400mg olaparib capsules |
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| Dietary standard | Other | Allocated breakfast prior to dosing with 400mg olaparib capsules |
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| Dietary High Fat | Other | Allocated breakfast prior to dosing with 400mg olaparib capsules |
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| AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue |
| Leuven |
| 3000 |
| Belgium |
| Research Site | Wilrijk | 2610 | Belgium |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Maastricht | 6202 AZ | Netherlands |
| Research Site | Glasgow | G12 0YN | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |