Neoplasm Malignant
Conditions
Brief summary
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.
Detailed description
Total duration of the study per patient is in the range of 17 to 29 weeks. This trial is being conducted in China, where the INN designation for the study molecule is aflibercept and this term is therefore used throughout the synopsis. In the US, the US proper name is ziv-aflibercept.
Interventions
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUGLeucovorin
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUGIrinotecan
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
DRUG5-Fluorouracil
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with standard safety assessments (adverse events and laboratory tests) | Up to last treatment + 30 days |
| Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU) | Up to last aflibercept administration + 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tumor activity assessment - overall response rate | Up to 17 Weeks |
| Anti-tumor activity assessment - duration response | Up to 17 Weeks |
| Anti-aflibercept antibody detection | Up to last aflibercept administration + 90 days |
Countries
China
Outcome results
None listed