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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479076
• Other study ID #: TED10089
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2007
• Last updated: January 25, 2011
• Start date: March 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities		during the first cycle of study treatment	Yes
Secondary	safety: physical examination, laboratory safety tests, adverse events		treatment period	Yes
Secondary	pharmacokinetic values		treatment period	No
Secondary	objective response rate		treatment period	No