A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

January 20, 2021 updated by: AbbVie

Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.

Study Overview

Status

Status

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

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.
70

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

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis /ID# 200693
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint /ID# 203101
      • Edegem, Belgium, 2650
        • UZ Antwerp /ID# 200694
      • Leuven, Belgium, 3000
        • UZ Leuven /ID# 200001
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 200691
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hospital Maisonneuve-Rosemont /ID# 171590
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital /ID# 171584
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 170878
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 170877
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 10408
        • National Cancer Center /ID# 170879
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 170875
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 200186
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 200189
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos /ID# 201721
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 200187
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro /ID# 200190
  • Taiwan
      • Taichung City, Taiwan, 40705
        • Taichung Veterans General Hosp /ID# 170123
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hosp /ID# 170675
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • National Taiwan Univ Hosp /ID# 170677
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224-5665
        • Ironwood Cancer & Res Ctr /ID# 200044
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703-4005
        • Highlands Oncology Group /ID# 169289
    • California
      • Duarte, California, United States, 91010
        • City of Hope /ID# 200501
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare /ID# 200100
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center /ID# 200410
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hosp Presbyterian /ID# 202661
      • Redondo Beach, California, United States, 90277-3036
        • Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center - Main /ID# 207227
      • San Luis Obispo, California, United States, 93401-7068
        • Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215
      • Santa Maria, California, United States, 93454-5909
        • Central Coast Medical Oncology /ID# 200227
      • Santa Monica, California, United States, 90404
        • University of California, Los /ID# 169294
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital /ID# 202903
    • Florida
      • Fort Myers, Florida, United States, 33901-8108
        • Florida Cancer Specialist - South /ID# 203796
      • Tallahassee, Florida, United States, 32308-5304
        • Florida Cancer Specialists-Panhandle /ID# 203787
    • Georgia
      • Columbus, Georgia, United States, 31904-8946
        • IACT Health /ID# 169292
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hosp /ID# 169892
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care, PC /ID# 202189
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology /ID# 201616
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas /ID# 200627
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute /ID# 200674
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation-New Orleans /ID# 169291
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Whiteside Institute for Clinic /ID# 200802
      • Saint Louis Park, Minnesota, United States, 55416
        • Mmcorc /Id# 202099
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School /ID# 200621
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska /ID# 203195
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital /ID# 169999
    • North Carolina
      • Durham, North Carolina, United States, 27710-3000
        • Duke University Medical Center /ID# 169657
    • Ohio
      • Cleveland, Ohio, United States, 44111-5605
        • Fairview Hospital - Moll Pavilion /ID# 205910
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus /ID# 200325
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital /ID# 205911
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109-3411
        • INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831
      • Oklahoma City, Oklahoma, United States, 73142
        • INTEGRIS Cancer Institute /ID# 200832
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University /ID# 170807
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Thomas Jefferson University /ID# 200833
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Ctr /ID# 200672
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System /ID# 203021
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1632
        • Tennessee Oncology-Nashville Centennial /ID# 203424
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC /ID# 203581
    • Texas
      • Dallas, Texas, United States, 75235-7709
        • Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112
      • Dallas, Texas, United States, 75390
        • UTSW-Dallas /ID# 204031
      • Houston, Texas, United States, 77090-1243
        • Millennium Oncology /ID# 204925
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists /ID# 169293
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and O /ID# 170811
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates /ID# 169290
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • Univ of Wisconsin Hosp/Clinics /ID# 200424

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:

  • Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.

    • Primary tumor has been resected > 3 months prior to randomization.
  • At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  • Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
  • Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

  • Any prior therapy with irinotecan
  • Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
  • Clinically significant conditions that increase the risk for antiangiogenic therapy.
  • History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.

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
  • Masking: NONE

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.
EXPERIMENTAL: ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Irinotecan
Intravenous
Other Names:
  • Irinotecan hydrochloride
Drug: Leucovorin
Intravenous
Other Names:
  • Folinic Acid
Drug: Fluorouracil - bolus
Intravenous
Other Names:
  • 5-FU
Drug: Fluorouracil - infusion
Intravenous
Other Names:
  • 5-FU
Drug: ABT-165
Intravenous
ACTIVE_COMPARATOR: Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Irinotecan
Intravenous
Other Names:
  • Irinotecan hydrochloride
Drug: Leucovorin
Intravenous
Other Names:
  • Folinic Acid
Drug: Bevacizumab
Intravenous
Other Names:
  • Avastin
Drug: Fluorouracil - bolus
Intravenous
Other Names:
  • 5-FU
Drug: Fluorouracil - infusion
Intravenous
Other Names:
  • 5-FU

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
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.
Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

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
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively
Overall Survival (OS)
Time Frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively
OS is defined as the time from randomization until death from any cause.
Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

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.
March 20, 2018

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.
December 18, 2019

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.
December 18, 2019

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).
December 6, 2017

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.
December 6, 2017

First Posted (ACTUAL)

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.
December 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
February 9, 2021

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.
January 20, 2021

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.
January 1, 2021

More Information

Terms related to this study

Keywords

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.
  • M14-064
  • 2017-003669-87 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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