drugset / Trial / NCT02395068
Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are ongoing all over the investigators' country. The main purpose of this study is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
Timeline
- Start
- 2012-11
- Primary completion
- 2014-11
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 100 mg | — |
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | — |
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | — |
| Subject | Nimotuzumab | Monoclonal antibody | 600 mg | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |