XRP9881 in Combination With Trastuzumab in Metastatic Bre... | NCT00386685

Studies
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

NCT00386685

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 12, 2011Estimated

Enrollment

51Actual

Phase

Phase 2

Conditions

Breast Neoplasms

Interventions

larotaxel (XRP9881)
trastuzumab

Countries

Belgium
France
Sweden
Switzerland

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

ID	Type	Description	Link
XRP9881

Status Module

Record Verification Date

Apr 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

Jul 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Jan 2011Actual

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

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

Apr 11, 2011

Last Update Posted Date

Apr 12, 2011Estimated

Description Module

Brief Summary

The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
larotaxel (XRP9881)	Drug	intravenous administration
trastuzumab	Drug	intravenous administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate (best overall response under treatment)		study period

Secondary Outcomes

Measure	Description	Time Frame
Incidence of grade 3-4 toxicities, pharmacokinetic interaction		study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic breast cancer (MBC)
HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
Adequate organs functions

Exclusion Criteria:

More than one previous chemotherapy regimen for metastatic disease
Cardiac dysfunction

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Henri Roche, PhD	Institut Claudius Regaud - Toulouse - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Diegem			Belgium
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531079	larotaxel
D000068878	Trastuzumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided