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

Stopped early · Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT03368859

Run by

AbbVie

People needed

70

Starts

2018-03-20

Expected to finish

2019-12-18

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of California, Los /ID# 169294 — Santa Monica, California, United States
• Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801 — Aurora, Colorado, United States
• Georgetown University Hospital /ID# 202903 — Washington D.C., District of Columbia, United States
• Florida Cancer Specialist - South /ID# 203796 — Fort Myers, Florida, United States
• Florida Cancer Specialists-Panhandle /ID# 203787 — Tallahassee, Florida, United States
• IACT Health /ID# 169292 — Columbus, Georgia, United States
• Ingalls Memorial Hosp /ID# 169892 — Harvey, Illinois, United States
• Illinois Cancer Care, PC /ID# 202189 — Peoria, Illinois, United States
• Fort Wayne Medical Oncology /ID# 201616 — Fort Wayne, Indiana, United States
• Cancer Center of Kansas /ID# 200627 — Wichita, Kansas, United States
• Norton Cancer Institute /ID# 200674 — Louisville, Kentucky, United States
• Ochsner Clinic Foundation-New Orleans /ID# 169291 — New Orleans, Louisiana, United States
• Whiteside Institute for Clinic /ID# 200802 — Duluth, Minnesota, United States
• Mmcorc /Id# 202099 — Saint Louis Park, Minnesota, United States
• Washington University School /ID# 200621 — St Louis, Missouri, United States
• Ironwood Cancer & Res Ctr /ID# 200044 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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