NCT01911598

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)

A Phase 1b Open-Label Study of the Safety and Pharmacokinetics of MEHD7945A in Combination With Either Cisplatin and 5-FU or Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	5-FU	5-FU will be administered as per schedule specified in the respective arm.
DRUG	Carboplatin	Carboplatin will be administered as per schedule specified in the respective arm.
DRUG	Cisplatin	Cisplatin will be administered as per schedule specified in the respective arm.
DRUG	MEHD7945A	MEHD7945A will be administered as per schedule specified in the respective arms.
DRUG	Paclitaxel	Paclitaxel will be administered as per schedule specified in the respective arm.

Timeline

• Start date: 2013-09-19
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2013-07-30
• Last updated: 2017-07-06

Locations

6 sites across 2 countries: United States, Belgium