Status:
TERMINATED
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Lead Sponsor:
Gilead Sciences
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 impro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT01479465
Start Date
December 1 2011
End Date
February 1 2015
Last Update
April 17 2019
Active Locations (109)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35801
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
3
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
4
Comprehensive Blood and Cancer Center
Bakersfield, California, United States