Pazopanib in Renal Cell Carcinoma after checkpoint inhibitor treatment
Research type
Research Study
Full title
A prospective international multicenter phase II study to evaluate the efficacy, safety and quality of life of oral daily pazopanib in patients with advanced and/or metastatic renal cell carcinoma after previous therapy with checkpoint inhibitor treatment
IRAS ID
227228
Contact name
Thomas Powles
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-000708-10
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Summary of Research
This study will test the safety and effects of pazopanib (Votrient®) on advanced and/or metastatic renal cell carcinoma, a kidney cancer that has spread to other organs of the body, after adult patients have had a type of cancer medication called a ‘checkpoint inhibitor’ and need to change to a new medication. Pazopanib interferes with the growth and spread of cancer cells in the body and is approved in the UK for advanced kidney cancer. Over 5900 people have received pazopanib in clinical trials and many more as a routine treatment for their cancer. The study will take place in hospital outpatient clinics. Pazopanib tablets are taken once a day until the study ends: 2 years after the last patient starts. Hospital visits will be four times in the first two months, monthly until Month 7 then every 8-12 weeks. Most visits include: blood and urine samples, general health check and quality of life questionnaires and heart imaging tests, and a CT or MRI scan to measure the cancer. Optionally, new tumour samples will be collected three times during the study.Summary of Results
Overall, at around 38 months after receiving pazopanib, the median length of time that participants lived after receiving treatment without their cancer getting worse was 6.8 months.
Looking at the median results, researchers found that the participants who took pazopanib as a second-line treatment lived longer without their cancer getting worse (PFS) than the participants who took pazopanib as a third-line treatment.
The proportion (percentage) of participants who took pazopanib as second-line treatment and experienced worsening of cancer or died was lower than those who took pazopanib as third-line treatment. The participants who took pazopanib as a second-line treatment were also more likely to show no worsening of cancer at 1 year than those who took pazopanib as a third-line treatment.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0452
Date of REC Opinion
3 Oct 2017
REC opinion
Further Information Favourable Opinion