Colorectal Neoplasms, Neoplasm Metastasis
Conditions
Keywords
oxaliplatin, 5-FU, Folinic Acid
Brief summary
The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer. Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Interventions
DRUGAVE0005 (aflibercept)
IV infusion
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable. * Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eligible for standard of care for safety reasons.
Exclusion criteria
* Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products, or any investigational agent within 28 days. * ECOG Performance Status\>1 * Anticipated need for a major surgical procedure or radiation therapy during the study. * Uncontrolled malignant ascites. * History of brain metastases, spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease on screening CT or MRI scan. * Pregnant or breast-feeding women. * Uncontrolled hypertension * Patients who have previously been treated with aflibercept * History of abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days. * History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine or isovorin. * Known dihydropyrimidine dehydrogenase deficiency. 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 |
|---|---|
| Dose-limiting toxicity (DLT) combination with FOLFIRI | During the first 2 cycles (4 weeks) of study treatment |
Secondary
| Measure | Time frame |
|---|---|
| physical examination, laboratory safety tests, adverse events | up to 60 days after last treatment |
| Pharmacokinetics | up to 90 days after last treatment |
| Tumor burden, endogenous free VEGF | every 3 cycles |
| Immunogenicity | up to 90 days after last treatment |
Countries
Japan
Outcome results
None listed