A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : placebo
  • drug : pazopanib

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Signed written informed consent - Diagnosis of RCC with clear-cell or predominant clear-cell histology - Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading. - pT2, G3 or G4, N0; or, - pT3, G any, N0; or, - pT4, G any, N0; or, - pT any, G any, N1 - Fulfill all of the following criteria of disease-free status at baseline: - Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique. - Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist. - Received no prior adjuvant or neo-adjuvant treatment for RCC - Recovered from nephrectomy: any surgery related toxicities should be reduced to ? grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4) - Karnofsky performance scale (KPS) of ? 80 - Adequate organ system function

External Links

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Contact information

Primary Contact:

Denise Haas 650736-1252

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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