Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Advanced Colorectal CancerAdenocarcinoma of the ColonAdenocarcinoma of the Rectum
Interventions
DRUG

ABT-869

12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle

DRUG

bevacizumab

10 mg/kg QD, IV on Day 1 of each 14-day cycle

DRUG

oxaliplatin

85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle

DRUG

folinic acid

400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle

DRUG

fluorouracil

400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours

DRUG

ABT-869

7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle

Trial Locations (46)

1200

Site Reference ID/Investigator# 23646, Brussels

2820

Site Reference ID/Investigator# 18023, Bonheiden

3000

Site Reference ID/Investigator# 18026, Leuven

4029

Site Reference ID/Investigator# 23443, Herston

5042

Site Reference ID/Investigator# 18581, Bedford Park

6021

Site Reference ID/Investigator# 20281, Wellington South

8800

Site Reference ID/Investigator# 18022, Roeselare

10513

Site Reference ID/Investigator# 20141, Olsztyn

15006

Site Reference ID/Investigator# 22809, A Coruña

19107

Site Reference ID/Investigator# 20801, Philadelphia

28034

Site Reference ID/Investigator# 22804, Madrid

28050

Site Reference ID/Investigator# 22801, Madrid

31008

Site Reference ID/Investigator# 22803, Pamplona Navarra

39008

Site Reference ID/Investigator# 22800, Santander

54007

Site Reference ID/Investigator# 22286, Thessaloniki

54769

Site Reference ID/Investigator# 22141, Náchod

56403

Site Reference ID/Investigator# 22287, Thessaloniki

71110

Site Reference ID/Investigator# 22289, Heraklion

115478

Site Reference ID/Investigator# 24422, Moscow

Site Reference ID/Investigator# 25063, Moscow

117997

Site Reference ID/Investigator# 25065, Moscow

143423

Site Reference ID/Investigator# 24423, Moscow

200385

Site Reference ID/Investigator# 23305, Craiova

400015

Site Reference ID/Investigator# 17961, Cluj-Napoca

430031

Site Reference ID/Investigator# 23303, Baia Mare

500117

Site Reference ID/Investigator# 23302, Brasov

27599-7305

Site Reference ID/Investigator# 11341, Chapel Hill

37232-6307

Site Reference ID/Investigator# 8360, Nashville

17210-120

Site Reference ID/Investigator# 26662, Jaú

90610-000

Site Reference ID/Investigator# 24245, Porto Alegre

L4M 6M2

Site Reference ID/Investigator# 23265, Barrie

T6G 1Z2

Site Reference ID/Investigator# 21083, Edmonton

K1H 8L6

Site Reference ID/Investigator# 22465, Ottawa

02-781

Site Reference ID/Investigator# 17946, Warsaw

04-125

Site Reference ID/Investigator# 38284, Warsaw

3814-501

Site Reference ID/Investigator# 23908, Aveiro

3001-651

Site Reference ID/Investigator# 22324, Coimbra

8000-386

Site Reference ID/Investigator# 23724, Faro

1099-023

Site Reference ID/Investigator# 23964, Lisbon

022328

Site Reference ID/Investigator# 17962, Bucharest

Site Reference ID/Investigator# 17964, Bucharest

050098

Site Reference ID/Investigator# 23304, Bucharest

110-744

Site Reference ID/Investigator# 18281, Seoul

135-710

Site Reference ID/Investigator# 18283, Seoul

138-736

Site Reference ID/Investigator# 18282, Seoul

08907

Site Reference ID/Investigator# 22807, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

AbbVie (prior sponsor, Abbott)

INDUSTRY