drugset / Trial / NCT00543504
Bevacizumab in Multiple Phase I Combinations
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to find the highest tolerable dose of Avastin™ that can be given in combination with 4 other study drug/drug combinations. It will be given with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a combination of trastuzumab and lapatinib. The safety and effectiveness of these drug combinations will also be studied.
Timeline
- Start
- 2007-10-10
- Primary completion
- 2020-04-29
- Completion
- 2020-04-29
Publications
- Subbiah V, Dumbrava EI, Jiang Y, Thein KZ, Naing A, Hong DS, Fu S, Piha-Paul SA, Tsimberidou AM, Janku F, Meric-Bernstam F, Kurzrock R, Falchook G. Dual EGFR blockade with cetuximab and erlotinib combined with anti-VEGF antibody bevacizumab in advanced solid tumors: a phase 1 dose escalation triplet combination trial. Exp Hematol Oncol. 2020 Apr 20;9:7. doi: 10.1186/s40164-020-00159-1. eCollection 2020.
- Falchook GS, Moulder SL, Wheler JJ, Jiang Y, Bastida CC, Kurzrock R. Dual HER2 inhibition in combination with anti-VEGF treatment is active in heavily pretreated HER2-positive breast cancer. Ann Oncol. 2013 Dec;24(12):3004-11. doi: 10.1093/annonc/mdt395. Epub 2013 Oct 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 75 mg/m2 | Intravenous |
| Subject | Erlotinib | Small molecule | 50 mg | Oral |
| Subject | Lapatinib | Small molecule | 250 mg | Oral |
| Subject | Sorafenib | Small molecule | 200 mg | Oral |
| Subject | Sunitinib | Small molecule | 12.5 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 1 mg/kg | Intravenous |