A Study of MEHD7945A in Combination With Cisplatin and 5-Fluorouracil (5-FU) or Paclitaxel and Carboplatin in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
Summary
This open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics, and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin + paclitaxel at the identified recommended Phase II dose.
Timeline
- Start
- 2013-09-19
- Primary completion
- 2017-06-22
- Completion
- 2017-06-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duligotuzumab | Monoclonal antibody | 1650 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 1000 mg/m2 | — |