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

This study is currently recruiting participants.

Verified by Sanofi-Aventis, March 2009

First Received: May 24, 2007 Last Updated: March 3, 2009 History of Changes

Sponsors and Collaborators:	Sanofi-Aventis Regeneron Pharmaceuticals
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00479076

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 I

MedlinePlus related topics: Cancer

Drug Information available for: S 1 (Combination) Aflibercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

Further study details as provided by Sanofi-Aventis:

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
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

intravenous infusion

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

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

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

Japan
Sanofi-Aventis Administrative Office	Recruiting
Tokyo, Japan
Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Regeneron Pharmaceuticals

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	TED10089
Study First Received:	May 24, 2007
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00479076 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

antineoplastic agents
VEGF Trap

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009