Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in
accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be
offered participation in this study during the consultation as part of their usual care. The
patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is
initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on "
alternating with 2 weeks "off "
As soon as a dose or schedule adjustment is required, regardless of cause, the patient will
be randomised 1/1:
Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in
accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks
Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen
(investigational arm); 2 weeks "on " alternating with 1 week "off "
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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