AN OPEN-LABEL SUNITINIB MALATE (SU011248) CONTINUATION
PROTOCOL FOR PATIENTS WHO HAVE COMPLETED A PRIOR SUNITINIB
STUDY AND ARE JUDGED BY THE INVESTIGATOR TO HAVE THE
POTENTIAL TO BENEFIT FROM SUNITINIB TREATMENT

Sunitinib malate (SUTENT®, SU011248) is approved by the US Food and Drug
Administration (FDA) for the treatment of gastrointestinal stromal tumor (GIST)
after disease progression on or intolerance to imatinib mesylate and for the
treatment of advanced renal cell carcinoma. Marketing Authorization has been
granted by the EU Commission for Sunitinib malate for the treatment of
unresectable and/or
metastatic malignant gastrointestinal stromal tumor after failure of imatinib
mesylate treatment due to resistance or intolerance and for the treatment of
advanced and/or metastatic renal cell carcinoma (MRCC) after failure of
interferon alfa or interleukin-2 therapy.

The safety and efficacy of sunitinib malate for the treatment of advanced
breast cancer and pancreatic islet cell tumor have not yet been determined and
are still investigational.

The objective of the study is to provide access to sunitinib treatment for
patients who have completed a prior sunitinib study and are judged by the
investigator to have the potential to benefit from sunitinib treatment. During
this study the duration of clinical benefit, the long-term safety and
tolerability of sunitinib, given in a continuous daily dose schedule, will be
assessed.

This is an open-label continuation protocol:

If the subject has previously been on sunitinib, he or she will begin treatment
at the dose used at the time of withdrawal from the previous parent trial. If
the subject has not previously been on sunitinib in one of the parent
protocols, a starting dose of 37.5 mg daily will be used.

Sunitinib-experienced subjects will return to clinic for a study visit at 4
weeks, and every 8 weeks thereafter.
Sunitinib-naïve subjects will return for their first four visits at 2, 4,
6, and 8 weeks and every 8 weeks thereafter.

Subjects may continue to access sunitinib on this protocol as long as there is
evidence of disease control and/or clinical benefit in the judgement of the
investigator.

There is no predetermined sample size for this study.

sunitinib malate (daily taken orally 25, 37,5 en 50 mg, dosis depends on the
prior sunitinib study of the subject)

Subjects will daily take sunitinib capsules orally. Physical examination and
blood draws will be performed.

The most common adverse events from sunitinib are fatigue and nausea, diarrhea,
constipation, dermatitis, hypertension, headache etc. (see informed consent
document). During the collection of blood samples, there is a risk of bruising,
pain, or infection at the site of the blood draw.