NCT00479076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

3.8 years

First QC Date

May 24, 2007

Last Update Submit

January 25, 2011

Conditions

Neoplasms

Keywords

antineoplastic agentsVEGF Trap

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • safety: physical examination, laboratory safety tests, adverse events

    treatment period

  • pharmacokinetic values

    treatment period

  • objective response rate

    treatment period

Interventions

aflibercept (AVE0005)DRUG

intravenous infusion

S-1DRUG

oral administration

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed cancer patients without standard of care
  • ECOG performance status 0, 1, or 2
  • Adequate organ and bone marrow function

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

afliberceptS 1 (combination)

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

JP(1)