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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AbbVie

Status and phase

Terminated
Phase 2

Conditions

Cancer

Treatments

Drug: Fluorouracil - infusion
Drug: Fluorouracil - bolus
Drug: Irinotecan
Drug: ABT-165
Drug: Bevacizumab
Drug: Leucovorin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03368859
2017-003669-87 (EudraCT Number)
M14-064

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

ABT-165 plus FOLFIRI
Experimental group
Description:
ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Treatment:
Drug: Leucovorin
Drug: ABT-165
Drug: Irinotecan
Drug: Fluorouracil - bolus
Drug: Fluorouracil - infusion
Bevacizumab plus FOLFIRI
Active Comparator group
Description:
Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Treatment:
Drug: Bevacizumab
Drug: Leucovorin
Drug: Irinotecan
Drug: Fluorouracil - bolus
Drug: Fluorouracil - infusion

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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