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 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. Pharmacokinetic blood sampling will be collected on cycle 1, day 14 and again
on day 14 when a stable sunitinib schedule has been established for each subject. Biomarker
and genomics blood sampling for correlation with progression free survival, toxicity and
pharmacokinetics will be collected at baseline and stored.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival for sunitinib given on an individualized dose/schedule
Primary objective is to characterize the progression free survival for sunitinib given on an individualized dose/schedule in patients on first-line treatment for metastatic renal cell cancer. Subjects will continue therapy until progression according to RECIST criteria version 1.1. Tumour measurements using physical exam, spiral CT scan and/or MRI or other appropriate techniques deemed suitable by the investigator will be performed at screening and repeated at the end of every 2 cycles until disease progression.
Georg A. Bjarnason, MD
Sunnybrook Health Sciences Centre
Canada: Health Canada