A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)

NCT ID: NCT01286818

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-03-31

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of the anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRI plus Ramucirumab (IMC-1121B)

Group Type: EXPERIMENTAL

Ramucirumab (IMC-1121B)

Intervention Type: BIOLOGICAL

Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks

Irinotecan

Intervention Type: DRUG

IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks

levofolinate

Intervention Type: DRUG

IV infusion, 200 mg/m² every 2 weeks

5-Fluorouracil (5-FU)

Intervention Type: DRUG

400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks

Interventions

Ramucirumab (IMC-1121B)

Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks

Intervention Type: BIOLOGICAL

Irinotecan

IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks

Intervention Type: DRUG

levofolinate

IV infusion, 200 mg/m² every 2 weeks

Intervention Type: DRUG

5-Fluorouracil (5-FU)

400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks

Intervention Type: DRUG

Other Intervention Names

IMC-1121B; Ramucirumab; LY3009806

Eligibility Criteria

Inclusion Criteria

• Participant is Japanese
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has histologically or cytologically confirmed CRC
• Has metastatic disease that is not amenable to potentially curative resection
• Has received no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted)
• Has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and has experienced disease progression during first-line therapy, or disease progression within 6 months after the last dose of first-line therapy, or discontinued part or all of first-line therapy due to toxicity and experienced disease progression within 6 months after the last dose of first-line therapy. Participants must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy in order to enroll.
• Has adequate hepatic, renal, hematologic, and coagulation function
• The participant's urinary protein is ≤1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <1000 milligrams (mg) of protein in 24 hours to allow participation in the study

Exclusion Criteria

• Has received bevacizumab within 28 days prior to study registration
• Has received chemotherapy within 21 days prior to study registration
• Has received any previous systemic therapy (other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine) for first-line treatment of metastatic CRC
• The participant experienced any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event; Grade 4 hypertension; Grade 4 proteinuria; a Grade 3-4 bleeding event; or bowel perforation
• Has received wide-field (full-dose pelvic) radiotherapy within 28 days prior to study registration
• Has undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to study registration
• Has elective or planned surgery to be conducted during the trial
• Has a history of deep vein thrombosis or pulmonary embolism within the past 12 months
• Has experienced any arterial thrombotic event within the past 12 months
• Participant is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents
• Participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin up to 325 milligrams per day (mg/day) permitted]
• Has a significant bleeding disorder or has had a significant (Grade 3 or higher) bleeding event within 3 months prior to registration date
• Has a history of gastrointestinal perforation and/or fistulae within 6 months prior to registration date
• Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
• Has uncontrolled arterial hypertension despite standard medical management
• Has a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to study registration
• Has an acute/subacute bowel obstruction or history of clinically significant chronic diarrhea
• Has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months prior to registration date
• The participant has either peptic ulcer disease associated with a bleeding event or known active diverticulitis
• Has an active infection requiring antibiotic, antifungal, or antiviral therapy
• Has known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
• Has known leptomeningeal or brain metastases or uncontrolled spinal cord compression
• Has a known history of Gilbert's Syndrome, or is known to have any of the following genotypes: uridine diphosphate glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*6/*6; UGT1A1*28/*28 or UGT1A1*6/*28
• Has previous or concurrent malignancy, except for basal or squamous cell skin cancer and/or in situ carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Chiba, , Japan

ImClone Investigational Site

Osaka, , Japan

ImClone Investigational Site

Shizuoka, , Japan

Countries

Japan

Other Identifiers

CP12-1029

Identifier Type: OTHER

Identifier Source: secondary_id

14T-IE-JVBY

Identifier Type: OTHER

Identifier Source: secondary_id

14223

Identifier Type: -

Identifier Source: org_study_id