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| ID | Type | Description | Link |
|---|---|---|---|
| D0810C00004 | |||
| 2007-000939-26 | EudraCT Number |
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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 carboplatin and/or Paclitaxel chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Carboplatin + KU-0059436 |
|
| 2. | Experimental | Paclitaxel + KU-0059436 |
|
| 3. | Experimental | Paclitaxel, Carboplatin + KU-0059436 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor) | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin | 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 |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Dr Johann de Bono, MD | Cancer Research UK, The Institute of Cancer Research, London, UK | Principal Investigator |
| Prof Jan HM Schellens | The Netherlands Cancer Institute, Amsterdam, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brussels | 1090 | Belgium | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31667659 | Derived | van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, de Bono JS, Schellens JHM. Phase I study of continuous olaparib capsule dosing in combination with carboplatin and/or paclitaxel (Part 1). Invest New Drugs. 2020 Aug;38(4):1117-1128. doi: 10.1007/s10637-019-00856-7. Epub 2019 Oct 30. | |
| 31637669 |
| Label | URL |
|---|---|
| KU36-96\_CSR\_Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| Carboplatin | Drug | intravenous injection |
|
|
| KU-0059436 (AZD2281)(PARP inhibitor) | Drug | Oral |
|
|
| Paclitaxel | Drug | Intravenous injection |
|
| KU-0059436 (AZD2281)(PARP inhibitor) | Drug | Oral |
|
|
| Paclitaxel + Carboplatin | Drug | Intravenous injection |
|
| Amsterdam |
| 1066 EC |
| Netherlands |
| Research Site | Rotterdam | 3015 | Netherlands |
| Research Site | London | SM2 5NG | United Kingdom |
| Derived |
| van der Noll R, Jager A, Ang JE, Marchetti S, Mergui-Roelvink MWJ, de Bono JS, Lolkema MP, de Jonge MJA, van der Biessen DA, Brunetto AT, Arkenau HT, Tchakov I, Beijnen JH, De Greve J, Schellens JHM. Phase I study of intermittent olaparib capsule or tablet dosing in combination with carboplatin and paclitaxel (part 2). Invest New Drugs. 2020 Aug;38(4):1096-1107. doi: 10.1007/s10637-019-00857-6. Epub 2019 Oct 21. |
| 22248721 | Derived | Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10. |
| revised\_CSP9 | View source |
| Study Results | View source |
| ID | Term |
|---|---|
| C531550 | olaparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C053518 | CP protocol |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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