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OpenTrials
Completed

NCT Number: NCT00174434

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Harvey, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: sunitinib malate, Sutent

paclitaxel

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.

Primary outcomes

  1. Safety of the combination of SU011248 and paclitaxel

    Time frame: 9/05-7/07

Secondary outcomes

  1. Pharmacokinetics of each medication

    Time frame: 9/05-7/07

  2. Objective disease response

    Time frame: 9/05-7/07

  3. Progression-free survival.

    Time frame: 9/05-7/07

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jan 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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