Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Colorectal Cancer
Interventions
DRUG

5-fluorouracil

Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter \[mg/m\^2\] administered as intravenous bolus and then 5-FU 2400 mg/m\^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.

DRUG

Cetuximab

Cetuximab 400 mg/m\^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m\^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity.

DRUG

Irinotecan

Standard Irinotecan chemotherapy (180 milligram per square meter \[mg/m\^2\] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.

DRUG

Leucovorin

Standard Leucovorin chemotherapy (400 mg/m\^2 \[racemic form\] or 200 mg/m\^2 \[L-isomer form\] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.

DRUG

MEHD7945A

MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.

Trial Locations (65)

1142

Auckland

1200

Brussels

2010

Darlinghurst

2065

St Leonards

2217

Sydney

2298

Waratah

2305

New Lambton Heights

2500

Wollongong

3000

Leuven

3112

Tauranga

3199

Frankston

4000

Liège

4029

Herston

4215

Southport

5041

Adelaide

7100

Haine-Saint-Paul

8011

Christchurch

9001

Dunedin

10043

Orbassano

19104

Philadelphia

20133

Milan

20162

Milan

20850

Rockville

28007

Madrid

28050

Madrid

32073

Orange Park

35128

Padua

42003

Paducah

46010

Valencia

48201

Detroit

54290

Trier

56100

Pisa

60426

Harvey

65109

Jefferson City

69373

Lyon

70199

Stuttgart

75015

Paris

80045

Aurora

81737

München

81925

München

89148

Las Vegas

90033

Los Angeles

90095

Los Angeles

92835

Fullerton

93105

Santa Barbara

93309

Bakersfield

93454

San Luis Obispo

94000

Créteil

94805

Villejuif

98034

Kirkland

98109

Seattle

500091

Brasov

700106

Iași

02114

Boston

02215

Boston

B6000

Charleroi

01307

Dresden

022328

Bucharest

030171

Bucharest

08035

Barcelona

08036

Barcelona

AB25 2ZN

Aberdeen

NW1 2BU

London

CH63 4JY

Metropolitan Borough of Wirral

OX3 7LJ

Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY