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

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: NCT00479076
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : January 26, 2011
Regeneron Pharmaceuticals
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Brief Summary:

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 or disease Intervention/treatment Phase
Neoplasms Drug: aflibercept (AVE0005) Drug: S-1 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: aflibercept (AVE0005)
    intravenous infusion
    Drug: S-1
    oral administration

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. safety: physical examination, laboratory safety tests, adverse events [ Time Frame: treatment period ]
  2. pharmacokinetic values [ Time Frame: treatment period ]
  3. objective response rate [ Time Frame: treatment period ]

Information from the National Library of Medicine

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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:

  • 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.

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): NCT00479076

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

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00479076     History of Changes
Other Study ID Numbers: TED10089
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by Sanofi:
antineoplastic agents