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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00479076
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 22
• Location: 1
• Duration (Months): 46.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2007
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. safety: physical examination, laboratory safety tests, adverse events [treatment period]

2. pharmacokinetic values [treatment period]

3. objective response rate [treatment period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Tokyo		Japan

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00479076
• Other Study ID Numbers: TED10089
• First Posted: May 25, 2007
• Last Update Posted: Jan 26, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: antineoplastic agents; VEGF Trap
• Additional relevant MeSH terms: Aflibercept

Study Results

No Results Posted as of Jan 26, 2011