NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-111571

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedColorectal Cancer
Date of first enrollment
Target sample size
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Ramucirumab Dosage And administration of the intervention : Either ramucirumab DP (8 mg/kg) or placebo (a volume equivalent to that of ramucirumab DP), administered as an IV infusion over 60 (+10) minutes on Day 1 of each cycle; then a 1-hour observation period following the initial and second infusions of investigational product; followed by the FOLFIRI regimen indicated in the following bullets Intervention name : Irinotecan (IRI) Dosage And administration of the intervention : 180 mg/m2 administered intravenously over 90 (±10) minutes, 1 hour after the end of the infusion of investigational product (or immediately after the infusion of investigational product if no observation period is required) on Day 1 of each cycle; followed by Intervention name : Folinic acid (FA) Dosage And administration of the intervention : 400 mg/m2 administered intravenously over 120 (±10) minutes on Day 1 of each cycle; followed by Intervention name : 5-Fluorouracil (5-FU) Dosage And administration of the intervention : 400 mg/m2 bolus over 2 to 4 minutes administered intravenously immediately following completion of the FA infusion on Day 1 of each cycle; followed by 5-Fluorouracil (5-FU): 2400 mg/m2 administered intravenously over 46 to 48 hours (continuously) on Days 1 and 2 of each cycle Control intervention name : null

Outcome(s)

Primary Outcomenull
Secondary Outcomenull

Key inclusion & exclusion criteria

Age minimum18
Age maximum
GenderBOTH
Include criteria- Histologically or cytologically confirmed metastatic colorectal cancer (patients are eligible to enroll irrespective of KRAS mutation status) - Confirmed metastatic colorectal cancer - The patient has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and a)Experienced radiographic disease progression during first-line therapy, or b)Experienced radiographic disease progression within 6 months after the last dose of first-line therapy, or c)Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first-line therapy; Note that a patient must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy; Note that a patient must not have received more than 2 different fluoropyrimidines as part of a first-line regimen; disease progression is not an acceptable reason for discontinuing one fluoropyrimidine and starting a second fluoropyrimidine - Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted); For patients with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen - Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic, renal, hepatic and coagulation function - Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available - Ability to provide signed informed consent
Exclude criteria- Receipt of bevacizumab within 28 days prior to randomization - Receipt of any investigational therapy within 28 days prior to randomization - Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer - Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression - Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to randomization - Pregnant (confirmed by serum beta human chorionic gonadotropin test within 7 days prior to randomization) or lactating - History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to randomization - Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator - Grade 3 or higher bleeding event within 3 months prior to randomization - Experience of 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 - Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 - Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments

Related Information

Contact

public contact
Name Eli Lilly Japan K.K. Lilly Answers
Address 0120-360-605
Telephone
E-mail
Affiliation
scientific contact
Name
Address
Telephone
E-mail
Affiliation