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

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Fluorouracil; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.