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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract No. 2008-007680-17 |
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The study will be an open label, multicenter, dose finding study. Depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be enrolled into this study. Three patients will be initially dosed in each cohort. The primary objective of this study is to determine the recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for 7 days out of a 28-day schedule or given continuously, administered in combination with liposomal doxorubicin to patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2281 | Drug | capsules, oral, bd, 2 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| recommended dose | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | 6 visits within 1 month | |
| safety/tolerability/toxicity | 2 months | |
| DNA repair mechanism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Milan | 20133 | Italy | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25025963 | Derived | Del Conte G, Sessa C, von Moos R, Vigano L, Digena T, Locatelli A, Gallerani E, Fasolo A, Tessari A, Cathomas R, Gianni L. Phase I study of olaparib in combination with liposomal doxorubicin in patients with advanced solid tumours. Br J Cancer. 2014 Aug 12;111(4):651-9. doi: 10.1038/bjc.2014.345. Epub 2014 Jul 15. |
| Label | URL |
|---|---|
| Study protocol | View source |
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| ID | Term |
|---|---|
| C531550 | olaparib |
| C506643 | liposomal doxorubicin |
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| liposomal doxorubicin | Drug | once every 4 weeks at 40mg/m2 |
|
| once |
| Bellinzona |
| CH-6500 |
| Switzerland |
| Research Site | Chur | CH-7000 | Switzerland |
| D0810L00001\_CSR\_Synopsis | View source |