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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT00707889
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABT-869 — DRUG
    12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
  • bevacizumab — DRUG
    10 mg/kg QD, IV on Day 1 of each 14-day cycle
  • oxaliplatin — DRUG
    85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
  • folinic acid — DRUG
    400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
  • fluorouracil — DRUG
    400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours
  • ABT-869 — DRUG
    7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle

Study Details

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

Key Dates

First listed
Jul 1, 2008
Start date
Oct 31, 2008
Status verified
May 2013
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
159 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Open-label to Bevacizumab plus mFOLFOX6
  • Active Comparator: B
    Open-label to High-dose ABT-869 arm plus mFOLFOX6
  • Active Comparator: C
    Open-label to low-dose ABT-869 arm plus mFOLFOX6

Primary Outcome Measure

Progression-free survival [ Time Frame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 11341Chapel HillNorth Carolina27599-7305-
Site Reference ID/Investigator# 20801PhiladelphiaPennsylvania19107-
Site Reference ID/Investigator# 8360NashvilleTennessee37232-6307-

Find similar trials in Chapel Hill, NC

By research site
Site Reference ID/Investigator# 11341· Chapel Hill, NCSite Reference ID/Investigator# 20801· Philadelphia, PASite Reference ID/Investigator# 8360· Nashville, TN

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