A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 15, 2013

Primary Completion Date

April 6, 2016

Study Completion Date

April 6, 2016

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

PF-05212384

30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.

DRUG

irinotecan

90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

DRUG

Cetuximab

120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1

DRUG

Irinotecan

90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Trial Locations (32)

14263

Roswell Park Cancer Institute, Buffalo

28009

Hospital General Universitario Gregorio Marañón, Madrid

63110

Barnes-Jewish Hospital, St Louis

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center - South County, St Louis

63141

Siteman Cancer Center - West County, Creve Coeur

63376

Siteman Cancer Center - St Peters, City of Saint Peters

89014

Regulatory Office: Comprehensive Cancer Centers of Nevada, Henderson

89052

Comprehensive Cancer Centers of Nevada, Henderson

89074

Comprehensive Cancer Centers of Nevada, Henderson

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90095

Regulatory Management Only: TRIO-US Central Administration, Los Angeles

TRIO-US Central Administration (Regulatory Management only), Los Angeles

TRIO_US, Los Angeles

91328

West Valley Hematology/Oncology Med Group, Northridge

93309

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield

99208

Medical Oncology Associates, PS, Spokane

99216

Spokane Valley Cancer Center, Spokane Valley

99336

Kadlec Clinic Hematology and Oncology, Kennewick

99352

Kadlec Medical Center, Richland

Outpatient Imaging Center, Richland

90095-7349

Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D, Los Angeles

Drug Management Only: UCLA West Medical Pharmacy, Los Angeles

UCLA West Medical Pharmacy, Los Angeles

464-8681

Aichi cancer center central hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

410-769

National Cancer Center, Goyang-si

110-744

Seoul National University Hospital / Department of Internal Medicine, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01925274 - A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter