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

NCT00707889 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2013-05-15

No results posted yet for this study

Summary

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.

Conditions

  • Advanced Colorectal Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma 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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Mark D. McKee, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Greece
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707889 on ClinicalTrials.gov