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Patients Required for Clinical Trials

All new drugs need to be vigorously tested to ensure they are safe and effective before they are licensed for use. Testing is conducted in the laboratory and in the clinic. Drugs are tested in the laboratory to ensure they are pharmacologically safe for human use. They are then tested in the clinic by administration to humans in clinical trials. The data collected during laboratory testing and clinical trials are compiled by the pharmaceutical company into a product license application. This application is submitted to the regulatory authority in each individual country to obtain a license to allow the pharmaceutical company to market and sell the drug.

CABOSUN trail shines for Cabozantinib

New CABOSUN Data Show Better PFS With Cabozantinib in mRCC

Read the full article HERE

Updated results from the phase II CABOSUN trial showed cabozantinib significantly prolonged progression-free survival (PFS) per independent review committee compared with sunitinib as first-line therapy for advanced renal cell carcinoma (RCC) of poor or intermediate risk.

Previously available results from CABOSUN showed improved investigator-assessed PFS, with a median PFS of 8.2 months for cabozantinib compared with 5.6 months for sunitinib (P = .012).

“The independent assessment confirms the investigator-assessed results for PFS and supports that cabozantinib is a potential treatment option as initial therapy for patients with advanced RCC of intermediate or poor risk,” Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and colleagues wrote in the European Journal of Cancer.

Clinical TrialsIn the trial, 157 treatment-naive patients with advanced RCC of intermediate or poor risk were randomly assigned to cabozantinib at 60-mg daily or sunitinib at 50-mg daily with 4 weeks on and 2 weeks off. Review by independent committee showed a significant improvement in PFS with cabozantinib. The median PFS was 8.6 months for cabozantinib compared with 5.3 months for sunitinib (hazard ratio [HR], 0.48; 95% CI, 0.31–0.74; P = .0008).

“The observed improvement in PFS with cabozantinib compared with sunitinib may be due, in part, to inhibition of MET and AXL by cabozantinib in addition to VEGF receptors,” the researchers wrote. “Subgroup analyses of PFS based on MET expression level favored cabozantinib over sunitinib (HR < 1) regardless of MET status.”

The overall response rate (ORR) was doubled with cabozantinib compared with sunitinib (20% vs 9%).

Read the full article HERE

Clinical Trials

Clinical Trials

Every year, more than half a million people help the NHS improve healthcare and develop life-saving treatments by taking part in clinical trials.

This is the UK Clinical Trials Gateway web site which provides information about clinical trials running in the UK and is designed to enable you and your clinician to locate and contact trials of interest to you.

You can find a list of clinical trials currently running for kidney cancer by clicking here .

The UK Clinical Trials Gateway is part of the National Institute of Health Research (the research arm of the NHS) and supported by a number of other organisations.

What are clinical trials? Find out more by clicking here

An Open Label Randomized Phase II Study Comparing Azd2014 Versus Everolimus In Patients With Advanced Metastatic Renal Cancer And Progression On VEGF Targeted Therapy

The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus. For details click here.

A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm

In this study, the investigators are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. The investigators are also looking at whether patients would be willing to be randomly assigned to a treatment group. The results of this study will then be compared to see how effective each of the treatments were and whether the number of patients who were happy to be randomly assigned to a treatment could be used to determine the number of patients required in a large-scale trial. For more information please click here.

An Open Label Randomized Phase II Study Comparing Azd2014 Versus Everolimus In Patients With Advanced Metastatic Renal Cancer And Progression On VEGF Targeted Therapy

The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus. For details click here.