E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

September 19, 2011

Primary Completion Date

January 31, 2016

Study Completion Date

September 4, 2017

Conditions
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

E7050

E7050 given orally at 200, 300, or 400 mg once daily.

DRUG

Cetuximab

Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.

Trial Locations (23)

3057

Kyiv

33905

Fort Myers

37203

Nashville

40005

Sumy

43623

Toledo

49102

Dnipropetrovsk

61024

Kharkiv

63110

St Louis

73104

Oklahoma City

83003

Donetsk

83092

Donetsk

85715

Tucson

02111

Boston

410-769

Goyang-si

519-763

Hwasun

602-739

Busan

110-744

Seoul

120-752

Seoul

135-710

Seoul

138-736

Seoul

NW1 2BU

London

M20 4BX

Manchester

G12 0YN

Glasgow

All Listed Sponsors
collaborator

PharmaBio Development Inc.

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT01332266 - E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter | Biotech Hunter