Clinical Trials /

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

NCT03368859

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine/ Oxaliplatin and Bevacizumab
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M14-064
  • SECONDARY ID: 2017-003669-87
  • NCT ID: NCT03368859

Conditions

  • Cancer

Interventions

DrugSynonymsArms
LeucovorinFolinic AcidABT-165 plus FOLFIRI
Fluorouracil - bolus5-FUABT-165 plus FOLFIRI
BevacizumabAvastinBevacizumab plus FOLFIRI
Fluorouracil - infusion5-FUABT-165 plus FOLFIRI
ABT-165ABT-165 plus FOLFIRI
IrinotecanIrinotecan hydrochlorideABT-165 plus FOLFIRI

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ABT-165 plus FOLFIRIExperimentalABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
  • Leucovorin
  • Fluorouracil - bolus
  • Fluorouracil - infusion
  • ABT-165
  • Irinotecan
Bevacizumab plus FOLFIRIActive ComparatorBevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
  • Leucovorin
  • Fluorouracil - bolus
  • Bevacizumab
  • Fluorouracil - infusion
  • Irinotecan

Eligibility Criteria

        Inclusion Criteria:

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

          -  At least 1 lesion on a computed tomography (CT) scan 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to 2 years following last subject enrolled
Safety Issue:
Description: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

Measure:Objective Response Rate (ORR)
Time Frame:Up to 30 days after last dose of study drug
Safety Issue:
Description: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.
Measure:Overall Survival (OS)
Time Frame:Up to 2 years after last dose of study drug
Safety Issue:
Description:OS is defined as the time from randomization until death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • cancer
  • colorectal cancer
  • ABT-165
  • FOLFIRI
  • Bevacizumab
  • bowel cancer
  • metastatic colorectal cancer
  • metastatic colorectal

Last Updated