drugset / Trial / NCT01360827
EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-04
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.16 mg/kg | Subcutaneous |
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.32 mg/kg | Subcutaneous |
| Subject | EMD 1201081 | Oligonucleotide (other) | 0.48 mg/kg | Subcutaneous |
| Background | Cetuximab | Monoclonal antibody | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | fluorouracil | Small molecule | — | — |