Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00921661
First received: June 15, 2009
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Neoplasm Metastasis |
Drug: AVE0005 (aflibercept) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Dose-limiting toxicity (DLT) combination with FOLFIRI [ Time Frame: During the first 2 cycles (4 weeks) of study treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- physical examination, laboratory safety tests, adverse events [ Time Frame: up to 60 days after last treatment ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: up to 90 days after last treatment ] [ Designated as safety issue: No ]
- Tumor burden, endogenous free VEGF [ Time Frame: every 3 cycles ] [ Designated as safety issue: No ]
- Immunogenicity [ Time Frame: up to 90 days after last treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 16 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AVE0005 (aflibercept) |
Drug: AVE0005 (aflibercept)
IV infusion
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00921661 History of Changes |
| Other Study ID Numbers: | TCD10794 |
| Study First Received: | June 15, 2009 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Sanofi:
|
oxaliplatin 5-FU Folinic Acid |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013