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Completed

NCT Number: NCT00322517

Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
  • Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.

Exclusion criteria

  • Prior treatment with >/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes
  • Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic

Treatment and study plan

SU014813

Drug

100 mg capsule/day for 6 cycle of 21 days

Primary outcomes

  1. To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC

    Time frame: June 2008

Secondary outcomes

  1. To assess onset and duration of tumor control and 1-year survival rate

    Time frame: AUG 2008

  2. To evaluate the safety of SU-014813To assess patient reported outcomes

    Time frame: AUG 2008

  3. To determine SU-014813 plasma trough concentration (Ctrough)

    Time frame: AUG 2008

  4. To explore the relationship between Ctrough and efficacy, safety, and biomarkers

    Time frame: AUG 2008

  5. To explore the correlations of cancer biomarkers with treatment-related outcomes

    Time frame: AUG 2008

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2 Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
May 8, 2006
Registry last updated
May 17, 2011

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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