Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

March 31, 2016

Study Completion Date

June 30, 2016

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

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.

DRUG

Cetuximab

Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.

DRUG

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).

DRUG

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).

Trial Locations (3)

SM2 5PT

The Royal Marsden Hospital, Sutton

NW1 2BU

University College London Hospital, London

SW3 6JJ

The Royal Marsden Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY