Clear Cell, Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II, Multi-Centre, Study of the Efficacy and Safety of Sunitinib Given on an Individualized Schedule as First-Line Therapy for Metastatic Renal Cell Cancer
This prospective single arm study will evaluate the efficacy and safety of sunitinib given on an individualized dosing schedule as first-line therapy in subjects with metastatic clear cell renal cell cancer. The treatment schedule intent is to maximize dose intensity of sunitinib and minimize time off therapy based on individual tolerability using protocol directed dose modification criteria. A total of 110 subjects will be enrolled. All subjects will continue to receive study treatment until disease progression or withdrawal of consent. The primary outcome for this study is progression-free survival (PFS), defined as the duration from the date a patient first receives Sunitinib until the date of death or confirmed progression according to the RECIST criteria.
This is a single-arm, single-stage phase II study investigating the use of an individualized
dosing regimen of Sunitinib on patients with metastatic renal cell carcinoma. The intent is
to maximize dose intensity of sunitinib and minimize time off therapy based on individual
tolerability using protocol directed dose modification criteria. Dose and schedule changes
are done if toxicity (hematological, fatigue, skin, GI) is > grade 2. There will be no dosing
or schedule changes for hypertension, hypothyroidism, skin color changes, heartburn, etc.
unless clinically indicated. Subjects will continue therapy until progression according to
RECIST 1.1 criteria. All subjects will be followed for progression free survival until
progression but after 2 years on therapy, only grade 3/4 drug related adverse events will be
recorded.
Fact-G and FKSI-DRS will be used to evaluate PRO/QOL at baseline and every 2 months
timepoints. A more detailed pharmacokinetic blood sampling will be done in a subset of
patients in an effort to understand if Sunitinib blood concentration has a tendency to go
down during treatment, as has been shown to be the case for Sorafenib. Biomarker and genomics
blood sampling for correlation with progression free survival, toxicity and pharmacokinetics
will be collected at baseline and stored.
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