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

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ClinicalTrials.gov Identifier: NCT03368859
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Leucovorin Drug: Fluorouracil - bolus Drug: Bevacizumab Drug: Fluorouracil - infusion Drug: ABT-165 Drug: Irinotecan Phase 2

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Study Type : Interventional
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: ABT-165 plus FOLFIRI
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Leucovorin
Intravenous
Other Name: Folinic Acid

Drug: Fluorouracil - bolus
Intravenous
Other Name: 5-FU

Drug: Fluorouracil - infusion
Intravenous
Other Name: 5-FU

Drug: ABT-165
Intravenous

Drug: Irinotecan
Intravenous
Other Name: Irinotecan hydrochloride

Active Comparator: Bevacizumab plus FOLFIRI
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Drug: Leucovorin
Intravenous
Other Name: Folinic Acid

Drug: Fluorouracil - bolus
Intravenous
Other Name: 5-FU

Drug: Bevacizumab
Intravenous
Other Name: Avastin

Drug: Fluorouracil - infusion
Intravenous
Other Name: 5-FU

Drug: Irinotecan
Intravenous
Other Name: Irinotecan hydrochloride




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 2 years following last subject enrolled ]
    PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by blinded independent central review or death from any cause.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 30 days after last dose of study drug ]
    ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a blinded independent central review based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

  2. Overall Survival (OS) [ Time Frame: Up to 2 years after last dose of study drug ]
    OS is defined as the time from randomization until death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368859


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03368859     History of Changes
Other Study ID Numbers: M14-064
2017-003669-87 ( EudraCT Number )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
cancer
colorectal cancer
ABT-165
FOLFIRI
Bevacizumab
bowel cancer
metastatic colorectal cancer
metastatic colorectal
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors