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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921661
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : November 9, 2012
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasm Metastasis Drug: AVE0005 (aflibercept) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AVE0005 (aflibercept) Drug: AVE0005 (aflibercept)
IV infusion

Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) combination with FOLFIRI [ Time Frame: During the first 2 cycles (4 weeks) of study treatment ]

Secondary Outcome Measures :
  1. physical examination, laboratory safety tests, adverse events [ Time Frame: up to 60 days after last treatment ]
  2. Pharmacokinetics [ Time Frame: up to 90 days after last treatment ]
  3. Tumor burden, endogenous free VEGF [ Time Frame: every 3 cycles ]
  4. Immunogenicity [ Time Frame: up to 90 days after last treatment ]

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921661

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00921661     History of Changes
Other Study ID Numbers: TCD10794
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Sanofi:
Folinic Acid

Additional relevant MeSH terms:
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