Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. [See Warnings and Precautions]
SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib.
Gastrointestinal Stromal Tumor (GIST)
SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Advanced Renal Cell Carcinoma (RCC)
SUTENT is indicated for the treatment of advanced renal cell carcinoma.
Advanced Pancreatic Neuroendocrine Tumors (pNET)
SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.
Published Studies Related to Sutent (Sunitinib)
Pazopanib versus sunitinib in metastatic renal-cell carcinoma. 
therapy... CONCLUSIONS: Pazopanib and sunitinib have similar efficacy, but the safety and
A randomized, double-blind, phase II study of erlotinib with or without sunitinib
for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). 
agents in platinum-pretreated non-small-cell lung cancer (NSCLC)... CONCLUSIONS: The addition of sunitinib to erlotinib did not significantly improve
Sunitinib plus erlotinib for the treatment of advanced/metastatic non-small-cell
lung cancer: a lead-in study. 
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.
Clinical Trials Related to Sutent (Sunitinib)
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer [Active, not recruiting]
This study is comparing a drug called Sutent with standard of care treatment for people with
advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and
effective treatment options are limited, new therapies are desperately needed.
This study is designed to see if Sutent following therapy with radioactive iodine will
target cancer cells and delay disease progression better than standard therapy alone. Newly
diagnosed patients, who are scheduled to receive radioactive iodine as part of their
standard care are possible candidates. By entering into this study, participants agree to
take oral Sutent for approximately one year after completing standard therapy. During this
time, study participants will be followed closely by their doctor.
A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma [Terminated]
Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly
with Sutent may show a radiologic response to the study drug (Sutent).
The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients
with localized kidney cancer. The purpose of this research is also to evaluate both the
safety and effectiveness of Sutent in this patient population.
A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma [Completed]
This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced
RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at
the maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation
portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks
of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of
both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week
cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0.
Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma [Active, not recruiting]
A majority of patients with bladder cancer have disease confined to the inner lining of the
bladder. Patients with high risk features (high grade tumors, tumors invading into a deeper
superficial layer) are routinely treated with Bacillus Calmette Guerin (BCG) instilled in
their bladder after the tumor has been removed. While up to 55% of patients respond to BCG,
failure to respond may suggest a more aggressive tumor that requires more definitive therapy
with complete bladder removal. BCG is believed to work by stimulating the body's own immune
system to attack tumor cells. It may also work by blocking the machinery that tumors use to
grow blood vessels which fuel tumor growth. A newer oral drug, sunitinib has shown to help
patients with metastatic bladder cancer by blocking new blood vessel growth (VEGF
inhibition). The investigators are studying the use of BCG followed by sunitinib in
patients with high risk non-muscle invasive bladder cancer to evaluate the complete response
(no visible evidence of tumor in the bladder) at 3 months and 6 months. The investigators
will also evaluate whether there is recurrent tumor at three years.
CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer [Recruiting]
Crizotinib is a medication that is taken by mouth. It has shown that it can help slow down
or stop the growth of tumor cells. The marketing name of the drug is "Xalkori". It has been
approved by the FDA (Food and Drug Administration) to treat other types of metastatic
cancer, but the investigators believe it may be helpful to treat breast cancer as well.
Sunitinib is the other medication used in the study. It is also taken by mouth in the form
of a capsule. The marketing name of this drug is "Sutent". It too has been approved by the
FDA to treat other types of cancer, but not for breast cancer.
In this study the investigators will be combining both of these two treatments, but at
One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25. 0 mg
once a day.
One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25. 0 mg
once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with
Sunitinib 37. 5 mg once a day.
Reports of Suspected Sutent (Sunitinib) Side Effects
Disease Progression (591),
Decreased Appetite (222),
Renal Cell Carcinoma (178), more >>
Page last updated: 2014-12-01