Phase II trial of imatinib (Gleevec) in patients with metastatic renal cell carcinoma
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Updated: Aug 14, 2026

Robotic Duodenal Sleeve Resection for Gastrointestinal Stromal Tumor with Rare Exon 8 KIT Mutation Following Neoadjuvant Imatinib
Published on: April 3, 2026
Jacqueline Vuky1, Christina Isacson, Mehran Fotoohi
1Section of Hematology/Oncology, Virginia Mason Hospital and Department of Medicine, University of Washington, Seattle, WA, USA. jacqueline.vuky@vmmc.org
Abstract:
Fourteen patients with metastatic renal cell carcinoma (RCC) were treated on a Phase II trial with imatinib. Eligible patients had histologically confirmed RCC, metastatic and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), Karnofsky performance status (KPS) of at least 70%, life expectancy of more than 3 months, and adequate hematological, renal, and liver function. Imatinib was given orally at a dose of 400 mg bid. The most common toxicities were Grade II/III nausea (28%) and Grade II renal insufficiency (14%). All patients had tumor tested by immunohistochemistry (IHC) for KIT protein (CD117, DAKO). One tumor (7%) demonstrated strong, diffuse expression and the rest were negative. No complete or partial responses were observed in 12 evaluable patients treated with imatinib.
Insights
This Phase II trial investigated imatinib for metastatic renal cell carcinoma (RCC). No patients achieved a response, indicating limited efficacy for this treatment in advanced RCC.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Metastatic renal cell carcinoma (RCC) presents a significant clinical challenge.
- Targeted therapies are crucial for improving outcomes in advanced RCC.
Purpose of the Study:
- To evaluate the efficacy and safety of imatinib in patients with metastatic renal cell carcinoma.
- To assess KIT (CD117) protein expression in RCC tumors treated with imatinib.
Main Methods:
- A Phase II clinical trial was conducted involving 14 patients with metastatic RCC.
- Patients received oral imatinib 400 mg twice daily.
- Tumor samples were analyzed for KIT protein expression using immunohistochemistry (IHC).
Main Results:
- No complete or partial responses were observed in the 12 evaluable patients.
- The most frequent toxicities included Grade II/III nausea (28%) and Grade II renal insufficiency (14%).
- Only one tumor (7%) showed strong, diffuse KIT protein expression; others were negative.
Conclusions:
- Imatinib demonstrated limited efficacy as a treatment for metastatic renal cell carcinoma in this study.
- The observed toxicities were manageable.
- Further research may be needed to identify predictive biomarkers for imatinib response in RCC.
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