Sutent (Sunitinib Malate) - Summary

SUTENT SUMMARY

SUTENT^® (sunitinib malate) capsules, oral

SUTENT, an oral multi-kinase inhibitor targeting several receptor tyrosine kinases (RTK), is the malate salt of sunitinib.

SUTENT is a multi-kinase inhibitor indicated for

• the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
• the treatment of advanced renal cell carcinoma (RCC).

NEWS HIGHLIGHTS

Published Studies Related to Sutent (Sunitinib)

Sunitinib plus erlotinib for the treatment of advanced/metastatic non-small-cell lung cancer: a lead-in study. [2012]
combination of sunitinib and erlotinib... CONCLUSION: A dosage of sunitinib 37.5 mg/d concurrently with erlotinib 150 mg/d

Long-term response with everolimus for metastatic renal cell carcinoma refractory to sunitinib. [2011.12]
A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib... This case illustrates the potential for patients with metastatic renal cell carcinoma, a malignancy with historically poor prognosis, to derive long-term benefit from everolimus when used in a manner consistent with its approved indication (after TKI therapy with sunitinib or sorafenib).

Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. [2011.07]
BACKGROUND: Combining targeted treatments for renal cell carcinoma has been suggested as a possible method to improve treatment efficacy. We aimed to assess the potential synergistic or additive effect of the combination of bevacizumab, directed against the VEGF receptor, and temsirolimus, an mTOR inhibitor, in metastatic renal cell carcinoma... INTERPRETATION: The toxicity of the temsirolimus and bevacizumab combination was much higher than anticipated and limited treatment continuation over time. Clinical activity was low compared with the benefit expected from sequential use of each targeted therapy. This combination cannot be recommended for first-line treatment in patients with metastatic renal cell carcinoma. FUNDING: French Ministry of Health and Wyeth Pharmaceuticals. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

An adjusted indirect comparison of everolimus and sorafenib therapy in sunitinib-refractory metastatic renal cell carcinoma patients using repeated matched samples. [2011.07]
CONCLUSION: Results suggest that sunitinib-refractory metastatic renal cell carcinoma patients treated with everolimus may experience significantly improved OS outcomes compared to those treated with sorafenib. However, because this is not a randomized controlled trial, the results should be interpreted as those from an observational study. (c) 2011 Informa UK, Ltd.

Phase II study of sunitinib malate in patients with recurrent high-grade glioma. [2011.07]
Receptor tyrosine kinase signaling causes profound neo-angiogenesis in high-grade gliomas (HGG)... Single-agent sunitinib at 37.5 mg/day had insufficient activity to warrant further investigation of this monotherapy regimen in recurrent HGG.

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Clinical Trials Related to Sutent (Sunitinib)

Ph I SU011248 + Irinotecan in Treatment of Pts w MG [Active, not recruiting]
Primary Objectives To determine maxi tolerated dose & dose limiting toxicity of SU011248 + Irinotecan in recurrent MG pts not on EIAEDs To characterize safety & tolerability of SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate pharmacokinetic profile of SU011248 & Irinotecan when co-administered in pts w MG To evaluate anti-tumor activity of SU011248 + Irinotecan

Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy [Active, not recruiting]
There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from rejecting organ transplants. Sirolimus is being tested for its effects against cancer because it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer growth in these animal models both by direct effects on the tumor cells, and also by blocking production of growth factors that stimulate production of blood vessels. We hope that the combined use of these two drugs will have better anti-cancer effects than either agent alone. This study is designed to find out if different doses of Sirolimus combined with a standard dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by cancer.

A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together [Active, not recruiting]
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors

Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy [Recruiting]
Objectives:

Primary -

1. To evaluate the pathological complete response (pCR) rate to neoadjuvant hormonal ablation and SU011248/sunitinib malate in high-risk localized prostate cancer.

Secondary -

1. To evaluate the time to PSA-progression after neoadjuvant hormonal ablation and SU011248/sunitinib malate, and Radical Prostatectomy (RP), in high-risk localized prostate cancer.

2. To evaluate the perioperative and postoperative morbidity with RP after neoadjuvant hormonal ablation and SU011248/sunitinib malate.

3. To identify and measure molecular biomarkers for neoadjuvant hormonal ablation and SU011248/sunitinib malate (optional studies).

Study of SU011248 in Combination With Docetaxel in Patients With Metastatic Breast Cancer [Active, not recruiting]
This study is to evaluate the safety of SU011248 in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

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Reports of Suspected Sutent (Sunitinib) Side Effects

Disease Progression (591),  Death (551),  Diarrhoea (367),  Fatigue (333),  Nausea (307),  Decreased Appetite (222),  Vomiting (211),  Asthenia (201),  Dysgeusia (182),  Renal Cell Carcinoma (178), more >>