drugset / Trial / NCT00516724
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-06-22
- Primary completion
- 2013-01-04
- Completion
- 2024-04-11
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 4 unknown | Intravenous |
| Subject | Olaparib | Small molecule | 50 mg | Oral |
| Subject | Olaparib | Small molecule | 100 mg | Oral |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |