15
Participants
Start Date
December 31, 2014
Primary Completion Date
March 31, 2016
Study Completion Date
June 30, 2016
Patritumab
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.
Cetuximab
Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.
Cisplatin
Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
Carboplatin
Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
The Royal Marsden Hospital, Sutton
University College London Hospital, London
The Royal Marsden Hospital, London
Lead Sponsor
Daiichi Sankyo
INDUSTRY