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A phase II study of everolimus in combination with imatinib for previously treated advanced renal carcinoma

Christopher W Ryan1, Jacqueline Vuky, Joseph S Chan

  • 1Oregon Health and Science University Knight Cancer Institute, Portland, OR 97239, USA. ryanc@ohsu.edu

Investigational New Drugs
|December 17, 2009
PubMed
Abstract

Insights

This study found that combining everolimus (an mTOR inhibitor) with imatinib (a PDGFR inhibitor) did not sufficiently improve progression-free survival in advanced renal carcinoma patients. Further investigation of this combination is not recommended.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Advanced renal carcinoma presents a significant treatment challenge.
  • Targeted therapies, including mTOR and PDGFR inhibitors, are crucial in managing renal cell carcinoma.
  • Combinatorial approaches are being explored to overcome treatment resistance.

Purpose of the Study:

  • To evaluate the efficacy of combining everolimus (mTOR inhibitor) with imatinib (PDGFR inhibitor) in previously treated advanced renal carcinoma patients.
  • To determine the 3-month progression-free rate as the primary endpoint for this combination therapy.

Main Methods:

  • A phase II clinical trial was conducted involving patients with metastatic or unresectable clear cell renal carcinoma.
  • Patients had received at least one prior systemic therapy but no prior mTOR inhibitor therapy.
  • Treatment involved daily oral administration of everolimus (2.5 mg) and imatinib (600 mg).

Main Results:

  • The study was terminated early due to insufficient patients achieving 3-month progression-free status.
  • The 3-month progression-free rate was 49% (95% CI 23%, 72%).
  • Median progression-free survival was 2.9 months (95% CI 1.9, 6.2), with common toxicities including nausea, elevated creatinine, edema, and fatigue.

Conclusions:

  • The combination of everolimus and imatinib did not achieve a sufficient 3-month progression-free rate in previously treated advanced renal carcinoma patients.
  • This combination therapy is not recommended for further investigation in this patient population.

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