Clinical trial · Interventional
A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)
A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| levofolinate | Drug | Levoleucovorin | ALIAS |
| Ramucirumab (IMC-1121B) | Biological | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI plus Ramucirumab (IMC-1121B)
- interventionNames
- Biological: Ramucirumab (IMC-1121B)
- Drug: Irinotecan
- Drug: levofolinate
- Drug: 5-Fluorouracil (5-FU)
Primary outcomes (2)
- measure
- Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period
- timeFrame
- Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days)
- description
- DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count \<1.0x10\^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein \>3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
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