Clinical trial · Interventional
A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies
- 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)
Primary Objective: To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors. Secondary Objectives: * To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1). * To evaluate the immunogenicity of IV aflibercept.
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 |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Aflibercept AVE0005 | Drug | Aflibercept | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
- interventionNames
- Drug: Aflibercept AVE0005
- Drug: Leucovorin
- Drug: Irinotecan
- Drug: 5-Fluorouracil
Primary outcomes (2)
- measure
- Number of patients with standard safety assessments (adverse events and laboratory tests)
- timeFrame
- Up to last treatment + 30 days
- measure
- Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
- timeFrame
- Up to last aflibercept administration + 90 days
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: \- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate Exclusion criteria: * Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days * Eastern Cooperative Oncology Group (ECOG) \>1 * Need for a major surgical procedure or radiation therapy during the study * Diagnosis of squamous-cell lung cancer * Cumulative radiation therapy to \> 25% of the total bone marrow * History of brain metastases * Inadequate organ and bone marrow function * Uncontrolled hypertension * Evidence of clinically significant bleeding diathesis or underlying coagulopathy * Prior FOLFIRI treatment but have not been appropriate for safety reasons * Patients with known Gilbert's syndrome The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available