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

NCT ID: NCT00174434

Last Updated: 2009-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-08-31

Brief Summary

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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

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

SU011248

Intervention Type 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.

Paclitaxel

Intervention Type DRUG

Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.

Interventions

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SU011248

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.

Intervention Type DRUG

Paclitaxel

Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.

Intervention Type DRUG

Other Intervention Names

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sunitinib malate, Sutent

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Harvey, Illinois, United States

Site Status

Pfizer Investigational Site

Harvey, Illinois, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Munster, Indiana, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A6181073

Identifier Type: -

Identifier Source: org_study_id

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