Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by second-line everolimus in metastatic and advanced renal cell carcinoma. Due to changes in the RCC treatment landscape, info gained is no longer clinically relevant to patients. Data collected is deemed sufficient to meet objective.
A non-randomised, open label, single-arm phase II study to evaluate the efficacy and safety of 1st-line pazopanib followed by 2nd-line everolimus in patients with previously untreated advanced or metastatic renal cell carcinoma. Subjects received initial therapy with pazopanib followed, on progression, by 2nd-line therapy with everolimus. Study treatment - sequential treatment with pazopanib followed by everolimus - to continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
74
All patients received Pazopanib (800 mg once daily orally continuous dosing) until disease progression then second line everolimus (10 mg once daily orally continuous dosing)
Novartis Investigative Site
Garran, Australian Capital Territory, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib. Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs).
Time frame: Throughout the study period, up to 4 years
Progression Free Survival (PFS) Rates
PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment.
Time frame: 3 months, 6 months
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Percentage of patients with Complete or Partial Response at any time following the start of second-line everolimus treatment as per RECIST. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Time frame: Throughout the study, up to 4 years
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Percentage of patients with Complete or Partial Response at any time following the start of first-line pazopanib treatment. RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Time frame: Throughout the study period, up to 4 years
Overall Survival of Everolimus (OSE)
Time from first everolimus dose until death due to any cause
Time frame: Throughout the study period, up to 4 years
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Auchenflower, Queensland, Australia
Novartis Investigative Site
Southport, Queensland, Australia
Novartis Investigative Site
Elizabeth Vale, South Australia, Australia
Novartis Investigative Site
Kurralta Park, South Australia, Australia
Novartis Investigative Site
Woodville, South Australia, Australia
Novartis Investigative Site
Footscay, Victoria, Australia
Novartis Investigative Site
Frankston, Victoria, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
...and 5 more locations
Overall Survival From the Start (OSS) of Study Treatment
Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus
Time frame: Throughout the study, up to 4 years
PFS for the Pazopanib Treatment Period Using RECIST
Time from first pazopanib dose until disease progression or death from any cause (whichever occurred earlier), provided this occurred prior to the start of everolimus and within 6 months of last dose of pazopanib
Time frame: Throughout the study period, up to 4 years