Study Of SU011248 In Combination With Paclitaxel In Patie... | NCT00174434

Studies
Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

NCT00174434

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jan 27, 2009Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Breast Neoplasms

Interventions

SU011248
Paclitaxel

Countries

United States

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 2008

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

Sep 2005

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

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 26, 2009

Last Update Posted Date

Jan 27, 2009Estimated

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

This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: SU011248 Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SU011248	Drug	SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of the combination of SU011248 and paclitaxel		9/05-7/07

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of each medication		9/05-7/07
Objective disease response		9/05-7/07
Progression-free survival.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
Candidate for treatment with paclitaxel.

Exclusion Criteria:

Prior chemotherapy in the advanced disease setting.
HER2 positive disease unless previously treated with trastuzumab.

Accepts Healthy Volunteers

Sex

All

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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Harvey	Illinois	60426-4265	United States
Pfizer Investigational Site

References Module

Citations

Not provided

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

ID	Term
D000077210	Sunitinib
D017239	Paclitaxel

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds