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Completed

NCT Number: NCT00054886

Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

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Key information

Conditions

Kidney Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Los Angeles, California, 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

  • Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
  • The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
  • Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function

Exclusion criteria

  • Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
  • Prior surgical resection of or irradiation to the only site of measurable disease;
  • Ongoing severe hematuria;
  • Other active second malignancy;
  • Cardiovascular diseases or conditions within the last 12 months;
  • Known brain metastases;
  • Known HIV-positive or AIDS-related illness;
  • Pregnant or breast-feeding women;
  • Current participation in other clinical trials;
  • Other severe acute or chronic medical conditions.

Treatment and study plan

SU-011,248

Drug

Primary outcomes

  1. The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

Secondary outcomes

  1. The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

Important dates

Study start
2003
Study completion
2004
First posted
Feb 13, 2003
Registry last updated
May 7, 2007

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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