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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer

NCT00707889•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be \>/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.
•Subject must have received one prior chemotherapy regimen containing irinotecan or a fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.
•Subject has experienced progressive disease during or following the previous anti-tumor treatment.
•Subject may have received prior adjuvant treatment for colorectal cancer. Subject has measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. Subject must have adequate bone marrow, renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) \< 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \< 1.5.

Exclusion Criteria

•Subject has received more than one prior therapy in the metastatic setting. Lead-in Cohort only: The subject may have received more than one prior therapy in the metastatic setting.
•Subject has received cytotoxic chemotherapy within 21 days prior to Study Day 1.
•Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period defined by 5 half lives whichever is shorter, prior to Study Day 1.
•Subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
•Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or PDGF.
•Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy as a result of the oxaliplatin treatment has resolved to less than or equal to Grade 1.
•Subject has had major surgery within 28 days of Study Day 1. Subject has had radiotherapy within 14 days of Study Day 1. Subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.
•Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a history of/or currently exhibits clinically significant cancer related events of bleeding.
•Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
•Subject has a history of myocardial infarction, stroke, or transient ischemic attack within six months of Study Day 1.
+1 more criteria

Locations (46)

Site Reference ID/Investigator# 11341

Chapel Hill, North Carolina, United States

Site Reference ID/Investigator# 20801

Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 8360

Nashville, Tennessee, United States

Site Reference ID/Investigator# 18581

Bedford Park, Australia

Site Reference ID/Investigator# 23443

Herston, Australia

Site Reference ID/Investigator# 18023

Bonheiden, Belgium

Site Reference ID/Investigator# 23646

Brussels, Belgium

Site Reference ID/Investigator# 18026

Leuven, Belgium

Site Reference ID/Investigator# 18022

Roeselare, Belgium

Site Reference ID/Investigator# 26662

Jaú, Brazil

Key Dates

Start Date

October 1, 2008

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

May 15, 2013

Enrollment

159

ACTUAL participants

Conditions

Advanced Colorectal CancerAdenocarcinoma of the ColonAdenocarcinoma of the Rectum

Interventions

ABT-869

DRUG

bevacizumab

DRUG

oxaliplatin

DRUG

folinic acid

DRUG

fluorouracil

DRUG

ABT-869

DRUG

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

NCT04668872

Colon Cancer Liver MetastasisColon Cancer+4 more

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RECRUITINGPHASE1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

NCT07321106

Colorectal CancerColorectal Cancer (CRC)+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies