Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921661

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014