NCT02383966View on ClinicalTrials.gov

Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

January 19, 2018

Study Completion Date

December 20, 2021

Conditions
Carcinoma, Squamous Cell of Head and Neck
Interventions
DRUG

Cetuximab

Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.

DRUG

Cisplatin/Carboplatin

Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.

DRUG

5-fluorouracil

Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.

Trial Locations (1)

Unknown

Research site, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT02383966 - Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer | Biotech Hunter | Biotech Hunter