A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

This study has been completed.
Regeneron Pharmaceuticals
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 24, 2007
Last updated: January 25, 2011
Last verified: January 2011

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

Condition Intervention Phase
Drug: aflibercept (AVE0005)
Drug: S-1
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities [ Time Frame: during the first cycle of study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety: physical examination, laboratory safety tests, adverse events [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]
  • pharmacokinetic values [ Time Frame: treatment period ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aflibercept (AVE0005)
    intravenous infusion
    Drug: S-1
    oral administration

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed cancer patients without standard of care
  • ECOG performance status 0, 1, or 2
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Need for a major surgery or radiation therapy during the study
  • History of hypersensitivity to S-1
  • Known dihydropyrimidine dehydrogenase deficiency
  • Uncontrolled hypertension
  • History of brain metastases
  • Ascites requiring drainage
  • Pregnancy or breastfeeding
  • Patients who have previously been treated with AVE0005

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479076

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

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00479076     History of Changes
Other Study ID Numbers: TED10089
Study First Received: May 24, 2007
Last Updated: January 25, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
antineoplastic agents

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014