Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

September 30, 2011

Conditions
Metastatic Colorectal CancerColon CancerColorectal CancerRectal Cancer
Interventions
DRUG

Placebo

Inactive dummy AMG 655 (to maintain blind)

DRUG

AMG 655

AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

DRUG

Modified FOLFOX6

Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)

DRUG

Bevacizumab

Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Trial Locations (61)

10021

Research Site, New York

10469

Research Site, The Bronx

12534

Research Site, Hudson

14263

Research Site, Buffalo

17109

Research Site, Harrisburg

17901

Research Site, Pottsville

19107

Research Site, Philadelphia

19718

Research Site, Newark

20007

Research Site, Washington D.C.

21215

Research Site, Baltimore

21237

Research Site, Baltimore

22031

Research Site, Fairfax

23235

Research Site, Richmond

23502

Research Site, Norfolk

27103

Research Site, Winston-Salem

27215

Research Site, Burlington

27607

Research Site, Raleigh

28054

Research Site, Gastonia

28801

Research Site, Asheville

29605

Research Site, Greenville

30045

Research Site, Lawrenceville

30309

Research Site, Atlanta

33136

Research Site, Miami

33176

Research Site, Miami

33486

Research Site, Boca Raton

34741

Research Site, Kissimmee

34788

Research Site, Leesburg

37203

Research Site, Nashville

38120

Research Site, Memphis

40202

Research Site, Louisville

43219

Research Site, Columbus

45042

Research Site, Middletown

45226

Research Site, Cincinnati

46227

Research Site, Indianapolis

49085

Research Site, Saint Joseph

55905

Research Site, Rochester

59405

Research Site, Great Falls

60153

Research Site, Maywood

60426

Research Site, Harvey

63136

Research Site, St Louis

66210

Research Site, Overland Park

71913

Research Site, Hot Springs

75080

Research Site, Richardson

75702

Research Site, Tyler

76310

Research Site, Wichita Falls

78731

Research Site, Austin

80218

Research Site, Denver

84403

Research Site, Ogden

90241

Research Site, Downey

92123

Research Site, San Diego

92270

Research Site, Rancho Mirage

92354

Research Site, Loma Linda

92868

Research Site, Orange

97227

Research Site, Portland

98405

Research Site, Tacoma

98684

Research Site, Vancouver

92093-0957

Research Site, La Jolla

02115

Research Site, Boston

48106-0995

Research Site, Ann Arbor

07740

Research Site, Long Branch

87109-4397

Research Site, Albuquerque

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00625651 - Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter