Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

Key facts

Study ID

NCT01479465

Run by

Gilead Sciences

People needed

266

Starts

2011-12-01

Expected to finish

2015-02-01

Last updated by the study team

2019-04-17

Who can join

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

You may qualify if…

• Metastatic colorectal carcinoma with KRAS mutation
• Received first line therapy and discontinued part or all of first line therapy
• Estimated life expectancy > 3 months
• Stage IV disease
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
• Adequate hepatic and hematologic function
• No major operations within 4 weeks prior to treatment start

You may not qualify if…

• More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer
• Experimental medical treatment within 30 days prior to study entry
• Known or suspected cerebral metastases
• History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment
• Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
• Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia
• Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at screening
• Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
• Prior irinotecan therapy for metastatic disease is not permitted
• Systemic fungal, bacterial, viral, or other infection
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Central Hematology Oncology Medical Group, Inc. — Alhambra, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Providence Saint Joseph Medical Center-Disney Family Cancer Center — Burbank, California, United States
• Wilshire Oncology Medical Group, Inc. — Corona, California, United States
• Saint Jude Heritage Healthcare — Fullerton, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Comprehensive Hematology Oncology Centers, Inc. — Los Angeles, California, United States
• TORI Network (Translational Oncology Research Intl) — Los Angeles, California, United States
• UCLA Community Oncology Practice — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Wilshire Oncology Medical Group, Inc. — Pomona, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• Pacific Shores Medical Group — Redondo Beach, California, United States
• Sharp Health Care — San Diego, California, United States
• San Jose Medical Group — San Jose, California, United States
• Central Coast Medical Oncology Corp — Santa Maria, California, United States
• Yale University Smilow Cancer Hospital — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Gainesville, Florida, United States
• MD Anderson Cancer Center — Orlando, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Peachtree Hematology Oncology Consultants, PC — Atlanta, Georgia, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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