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| ID | Type | Description | Link |
|---|---|---|---|
| D0810C00005 |
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The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Gemcitabine + KU-0059436 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor) | Drug | oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine | assessed at each visit |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the dose-limiting toxicity of the combination therapy | assessed at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard A Burris III, MD | The Sarah Cannon Cancer Center | Principal Investigator |
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New York | New York | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25573533 | Derived | Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7. |
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| Gemcitabine | Drug | intravenous injection |
|
|
| Nashville |
| Tennessee |
| United States |
| Research Site | London | United Kingdom |
| Research Site | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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