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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Cancer

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

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)

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70 participants in 2 patient groups

ABT-165 plus FOLFIRI

Experimental group

Description:

ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).

Treatment:

Drug: ABT-165

Drug: Leucovorin

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