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

May 7, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Site Reference ID/Investigator# 18581
      • Herston, Australia, 4029
        • Site Reference ID/Investigator# 23443
  • Belgium
      • Bonheiden, Belgium, 2820
        • Site Reference ID/Investigator# 18023
      • Brussels, Belgium, 1200
        • Site Reference ID/Investigator# 23646
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator# 18026
      • Roeselare, Belgium, 8800
        • Site Reference ID/Investigator# 18022
  • Brazil
      • Jau, Brazil, 17210-120
        • Site Reference ID/Investigator# 26662
      • Porto Alegre, Brazil, 90610-000
        • Site Reference ID/Investigator# 24245
  • Canada
      • Barrie, Canada, L4M 6M2
        • Site Reference ID/Investigator# 23265
      • Edmonton, Canada, T6G 1Z2
        • Site Reference ID/Investigator# 21083
      • Ottawa, Canada, K1H 8L6
        • Site Reference ID/Investigator# 22465
  • Czech Republic
      • Nachod, Czech Republic, 54769
        • Site Reference ID/Investigator# 22141
  • Greece
      • Heraklion, Greece, 71110
        • Site Reference ID/Investigator# 22289
      • Thessaloniki, Greece, 54007
        • Site Reference ID/Investigator# 22286
      • Thessaloniki, Greece, 56403
        • Site Reference ID/Investigator# 22287
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Site Reference ID/Investigator# 18281
      • Seoul, Korea, Republic of, 135-710
        • Site Reference ID/Investigator# 18283
      • Seoul, Korea, Republic of, 138-736
        • Site Reference ID/Investigator# 18282
  • New Zealand
      • Wellington South, New Zealand, 6021
        • Site Reference ID/Investigator# 20281
  • Poland
      • Olsztyn, Poland, 10513
        • Site Reference ID/Investigator# 20141
      • Warsaw, Poland, 02-781
        • Site Reference ID/Investigator# 17946
      • Warsaw, Poland, 04-125
        • Site Reference ID/Investigator# 38284
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Site Reference ID/Investigator# 23908
      • Coimbra, Portugal, 3001-651
        • Site Reference ID/Investigator# 22324
      • Faro, Portugal, 8000-386
        • Site Reference ID/Investigator# 23724
      • Lisbon, Portugal, 1099-023
        • Site Reference ID/Investigator# 23964
  • Romania
      • Baia Mare, Romania, 430031
        • Site Reference ID/Investigator# 23303
      • Brasov, Romania, 500117
        • Site Reference ID/Investigator# 23302
      • Bucharest, Romania, 022328
        • Site Reference ID/Investigator# 17962
      • Bucharest, Romania, 022328
        • Site Reference ID/Investigator# 17964
      • Bucharest, Romania, 050098
        • Site Reference ID/Investigator# 23304
      • Cluj Napoca, Romania, 400015
        • Site Reference ID/Investigator# 17961
      • Craiova, Romania, 200385
        • Site Reference ID/Investigator# 23305
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Site Reference ID/Investigator# 24422
      • Moscow, Russian Federation, 115478
        • Site Reference ID/Investigator# 25063
      • Moscow, Russian Federation, 117997
        • Site Reference ID/Investigator# 25065
      • Moscow, Russian Federation, 143423
        • Site Reference ID/Investigator# 24423
  • Spain
      • A Coruna, Spain, 15006
        • Site Reference ID/Investigator# 22809
      • Barcelona, Spain, 08907
        • Site Reference ID/Investigator# 22807
      • Madrid, Spain, 28034
        • Site Reference ID/Investigator# 22804
      • Madrid, Spain, 28050
        • Site Reference ID/Investigator# 22801
      • Pamplona Navarra, Spain, 31008
        • Site Reference ID/Investigator# 22803
      • Santander, Spain, 39008
        • Site Reference ID/Investigator# 22800
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
        • Site Reference ID/Investigator# 11341
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Site Reference ID/Investigator# 20801
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Site Reference ID/Investigator# 8360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

History of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
Open-label to Bevacizumab plus mFOLFOX6
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
Other Names:
  • mFOLFOX6 regimen
Drug: folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen
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
Other Names:
  • mFOLFOX6 regimen
Active Comparator: B
Open-label to High-dose ABT-869 arm plus mFOLFOX6
Drug: oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen
Drug: folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen
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
Other Names:
  • mFOLFOX6 regimen
Drug: ABT-869
12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
Drug: ABT-869
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle
Active Comparator: C
Open-label to low-dose ABT-869 arm plus mFOLFOX6
Drug: oxaliplatin
85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen
Drug: folinic acid
400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle
Other Names:
  • mFOLFOX6 regimen
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
Other Names:
  • mFOLFOX6 regimen
Drug: ABT-869
12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle
Drug: ABT-869
7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival
Time Frame: Radiographic evaluation every 2 months, clinial evaluation every 2 weeks
Radiographic evaluation every 2 months, clinial evaluation every 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: from randomization until patient death or alive at 5 years
from randomization until patient death or alive at 5 years
12-month overall survival rate
Time Frame: from randomization until patient death or alive at 5 years
from randomization until patient death or alive at 5 years
Objective response rate
Time Frame: from randomization until patient death or alive at 5 years
from randomization until patient death or alive at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mark D. McKee, MD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M10-300
  • 2007-007081-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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