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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00479076
First received: May 24, 2007
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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
Neoplasms
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
  Eligibility

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

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
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: NCT00479076

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

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
VEGF Trap

ClinicalTrials.gov processed this record on October 22, 2014