TARGET Phase III Clinical Trial Design and Results
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Proven Efficacy and Safety in the Largest Phase III Study for Advanced Renal Cell Carcinoma (RCC)2,6*

TARGET† — largest phase III randomised, double-blind, placebo-controlled, multinational, multicentre trial:

  • Compared the efficacy and safety of Nexavar vs placebo in patients with advanced RCC who had received one prior systemic therapy
  • Primary study end point was overall survival (OS)
  • Secondary end points included progression-free survival (PFS), tumour response rate, and quality of life
    • Best overall tumour response rate defined by RECIST criteria‡

†Treatment Approaches in Renal Cancer Global Evaluation Trial

‡RECIST criteria: Complete response (CR) = disappearance of all target lesions, confirmed at 4 weeks; Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD) = at least a 20% increase in the sum of the LD of target lesions; no CR, PR, or SD documented before increased disease.

*Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha- or interleukin-2-based therapy or are considered unsuitable for such therapy.

Study design2

TARGET — Nexavar Study design

Patient characteristics2

Well-balanced treatment arms

  • Patient groups were well balanced for age, ECOG performance status, risk category, and prior cytokine therapy

Demographics and baseline patient characteristics


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