Sunitinib Treatment Of Renal Adjuvant Cancer (s-TRAC): A Randomized Double-Blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent RCC

Trial Profile

Sunitinib Treatment Of Renal Adjuvant Cancer (s-TRAC): A Randomized Double-Blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent RCC

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2018

At a glance

  • Drugs Sunitinib (Primary)
  • Indications Renal cell carcinoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms S-TRAC; S-TRAC
  • Sponsors Pfizer
  • Most Recent Events

    • 09 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 16 Nov 2017 According to a Pfizer media release, the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from this trial.
    • 19 Sep 2017 According to a Pfizer media release, FDA's Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
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