Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combinati... | NCT00467012

Studies
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

NCT00467012

Sponsor

Chugai Pharmaceutical

Status

Completed

Last Update Posted

Apr 26, 2012Estimated

Enrollment

122Actual

Phase

Phase 2

Conditions

Metastatic Breast Cancer

Interventions

bevacizumab
Paclitaxel

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

Apr 2012

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

Apr 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Sep 2011Actual

First Submitted Date

Apr 26, 2007

First Submission Date that Met QC Criteria

Apr 26, 2007

First Posted Date

Apr 27, 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

Apr 25, 2012

Last Update Posted Date

Apr 26, 2012Estimated

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

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

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

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
step 1	Experimental	6 enrollment for 1 cycle(4 weeks)	Drug: bevacizumab Drug: Paclitaxel
step 2	Experimental	114 enrollment through to meet the stopping criteria	Drug: bevacizumab Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	10mg/kg，Day1, 15 of 1 cycle(4 weeks)	step 1 step 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety		throughout study
Progression-free survival (PFS)		event driven

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival(OS)		event driven
Time to Treatment Failure(TTF)		evnt driven
Response Rate(RR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

At least 20 years old and obtained a written informed consent
Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
HER2 negative
At least one measurable lesion based on RECIST criteria
No previous chemotherapy for metastatic breast cancer

Accepts Healthy Volunteers

Sex

Female

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
Shingo Koganezawa	Clinical research department 3	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanto Region		Kanto			Japan
Kinki Region

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D017239	Paclitaxel

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided