A Phase I Study of Intravenous Aflibercept in Combination... | NCT00545246

Studies
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

NCT00545246

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 16, 2013Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

aflibercept (AVE0005)
docetaxel

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

Oct 2013

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

Oct 2007

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Oct 16, 2007

First Submission Date that Met QC Criteria

Oct 16, 2007

First Posted Date

Oct 17, 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

Oct 12, 2013

Last Update Posted Date

Oct 16, 2013Estimated

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, 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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aflibercept + docetaxel	Experimental		Drug: aflibercept (AVE0005) Drug: docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aflibercept (AVE0005)	Drug	intravenous infusion	aflibercept + docetaxel

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		first 3-week cycle

Secondary Outcomes

Measure	Description	Time Frame
safety: physical examination, laboratory safety tests, adverse events		up to 60 days after last treatment
pharmacokinetic values		every 3-week cycle
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 or 1
Adequate organ and bone marrow function

Exclusion Criteria:

Need for a major surgery or radiation therapy during the study
History of hypersensitivity to docetaxel or polysorbate 80
Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
Uncontrolled hypertension
History of brain metastases
Ascites requiring drainage
Pregnancy or breastfeeding
Patients who have previously been treated with aflibercept.

The investigator will evaluate whether there are other reasons why a patient may not participate.

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 Investigational Site Number 392002		Iruma-gun			Japan
Sanofi-Aventis Investigational Site Number 392001

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35771301	Derived	Sunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30.

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

ID	Term
C533178	aflibercept
D000077143	Docetaxel