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Investigational New Drugs

, Volume 23, Issue 6, pp 577–581 | Cite as

Phase II study of the efficacy and safety of oral GD0039 in patients with locally advanced or metastatic renal cell carcinoma

  • Philip E. Shaheen
  • Walter Stadler
  • Paul Elson
  • Jennifer Knox
  • Eric Winquist
  • Ronald M. Bukowski
Article

Abstract

Seventeen patients with locally advanced or metastatic renal cell carcinoma (RCC) were enrolled in this phase II trial. The purpose of the trial was to assess the efficacy of the administration of oral GD0039, and to further assess the pharmacokinetics and pharmacodynamics of this drug. Patients were given an initial dose of 37.5 μ g/kg b.i.d for 3 weeks followed by one week off in each cycle, with the treatment continuing until disease progression or adverse effects. All 17 patients discontinued treatment due to disease progression or toxicity. Adverse events such as fatigue, nausea and diarrhea were common but generally mild. No evidence of anti-tumor activity of GD0039 was seen in this study.

Keywords

GD0039 renal cell carcinoma phase II trial 

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Copyright information

© Springer Science + Business Media, Inc. 2005

Authors and Affiliations

  • Philip E. Shaheen
    • 1
  • Walter Stadler
    • 2
  • Paul Elson
    • 3
  • Jennifer Knox
    • 4
  • Eric Winquist
    • 5
  • Ronald M. Bukowski
    • 1
    • 6
  1. 1.Experimental Therapeutics Program, Taussig Cancer CenterCleveland Clinic FoundationUnited States
  2. 2.University of Chicago Medical CenterChicagoUnited States
  3. 3.Biostatistics and Epidemiology, Taussig Cancer CenterCleveland Clinic FoundationClevelandUnited States
  4. 4.Princess Margaret HospitalTorontoCanada
  5. 5.London Health Sciences CenterLondonCanada
  6. 6.Taussig Cancer Center, R33, Cleveland Clinic FoundationClevelandUSA

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