Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01286818
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01286818
Study Brief:
Protocol Section:
NCT01286818