drugset / Trial / NCT00809133
Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours
Non-randomizedOpen-labelTreatment
Summary
The main purpose of this study is to assess the optimum dose of the following medications when they are given together: * BIBW 2992 and paclitaxel (Taxol) * BIBW 2992 and paclitaxel and bevacizumab (Avastin) * BIBW 2992 and carboplatin * BIBW 2992 and paclitaxel and carboplatin The effect of the different drug combinations will also be assessed.
Timeline
- Start
- 2007-05
- Primary completion
- 2015-02
- Completion
- 2015-02
Publications
- O'Brien MER, Sarker D, Bhosle J, Thillai K, Yap TA, Uttenreuther-Fischer M, Pemberton K, Jin X, Wiebe S, de Bono J, Spicer J. A phase I study to assess afatinib in combination with carboplatin or with carboplatin plus paclitaxel in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2018 Nov;82(5):757-766. doi: 10.1007/s00280-018-3661-1. Epub 2018 Aug 7.
- Suder A, Ang JE, Kyle F, Harris D, Rudman S, Kristeleit R, Solca F, Uttenreuther-Fischer M, Pemberton K, Pelling K, Schnell D, de Bono J, Spicer J. A phase I study of daily afatinib, an irreversible ErbB family blocker, in combination with weekly paclitaxel in patients with advanced solid tumours. Eur J Cancer. 2015 Nov;51(16):2275-84. doi: 10.1016/j.ejca.2015.07.041. Epub 2015 Aug 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 20 mg | Oral |
| Subject | Afatinib | Small molecule | 30 mg | Oral |
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Afatinib | Small molecule | 50 mg | Oral |
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | — |
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |