A Phase I Study of Intravenous Aflibercept in Combination... | NCT00479076

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

NCT00479076

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jan 26, 2011Estimated

Enrollment

22Estimated

Phase

Phase 1

Conditions

Neoplasms

Interventions

aflibercept (AVE0005)
S-1

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 24, 2007

First Submission Date that Met QC Criteria

May 24, 2007

First Posted Date

May 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2011

Last Update Posted Date

Jan 26, 2011Estimated

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aflibercept (AVE0005)	Drug	intravenous infusion
S-1	Drug	oral administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
safety: physical examination, laboratory safety tests, adverse events		treatment period
pharmacokinetic values		treatment period
objective response rate

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C533178	aflibercept
C079198	S 1 (combination)

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided