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

Phase 2

Terminated

• Conditions: Cancer
• Interventions: Drug: Leucovorin; Drug: Fluorouracil - bolus; Drug: Fluorouracil - infusion; Drug: Bevacizumab; Drug: ABT-165; Drug: Irinotecan

• Registration Number: NCT03368859
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-11
• Study Start: 2018-03-20
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Results First Submitted: 2020-11-17
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Results First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-165 plus FOLFIRI	ABT-165	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI	Fluorouracil - bolus	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
ABT-165 plus FOLFIRI	Fluorouracil - bolus	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
ABT-165 plus FOLFIRI	Fluorouracil - infusion	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI	Fluorouracil - infusion	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
ABT-165 plus FOLFIRI	Leucovorin	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
ABT-165 plus FOLFIRI	Irinotecan	ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI	Leucovorin	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI	Bevacizumab	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Bevacizumab plus FOLFIRI	Irinotecan	Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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.
Overall Survival (OS)	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.

Trial Locations

Locations (65)

Ironwood Cancer & Res Ctr /ID# 200044; 🇺🇸 Chandler, Arizona, United States

Highlands Oncology Group /ID# 169289; 🇺🇸 Fayetteville, Arkansas, United States

City of Hope /ID# 200501; 🇺🇸 Duarte, California, United States

St. Joseph Heritage Healthcare /ID# 200100; 🇺🇸 Fullerton, California, United States

USC Norris Cancer Center /ID# 200410; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hosp Presbyterian /ID# 202661; 🇺🇸 Newport Beach, California, United States

Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488; 🇺🇸 Redondo Beach, California, United States

UC Davis Comprehensive Cancer Center - Main /ID# 207227; 🇺🇸 Sacramento, California, United States

Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215; 🇺🇸 San Luis Obispo, California, United States

Central Coast Medical Oncology /ID# 200227; 🇺🇸 Santa Maria, California, United States

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