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Completed

NCT Number: NCT00479076

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

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.

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (AVE0005)

Drug

intravenous infusion

S-1

Drug

oral administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 25, 2007
Registry last updated
Jan 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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