A-PREDICT

• Research type

  Research Study

• Full title

  A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy

• IRAS ID

  98117

• Contact name

  James Larkin

• Sponsor organisation

  Institute of Cancer Research

• Eudract number

  2011-004562-16

• ISRCTN Number

  ISRCTN

• Research summary

  Summary of Research

  The A-PREDICT study is investigating whether treatment with a new drug, axitinib, can help people with a type of kidney cancer diagnosed when it has spread throughout their body, when surgery to remove their kidney (nephrectomy) is not possible. This type of cancer is called metastatic renal cell carcinoma. Axitinib has been found to help people with renal cell carcinoma who have already received previous treatment, but A-PREDICT aims to find out if axitinib can help people who have not yet had any treatment. An important part of A-PREDICT will look at biological samples donated by participants. This is to see if there is anything that will predict who axitinib treatment will work best for - at the moment very little is known about who should receive which treatment in this sort of cancer. Axitinib is a tablet, which participants will need to take twice a day. They will continue to take axitinib as long as it is helping to prevent their cancer from getting worse, and will have regular check ups at their hospital to see how they are getting on. Participants will be asked to donate samples from their cancer, and from places to which the cancer has spread (metastatic sites of disease). Samples will be taken before they start treatment, 8 weeks after starting treatment, and when they stop treatment. Because this is a very important part of the study, we will ask that people only join A-PREDICT if they think they will be willing to provide these samples, although they will be free to change their minds during the course of the study. The main aim of A-PREDICT is to find out how well axitinib controls the spread of renal cell carcinoma in the first six months of treatment.

  Summary of Results

  Research summary
  The A-PREDICT study is investigating whether treatment with a new drug, axitinib, can help people with a type of kidney cancer diagnosed when it has spread throughout their body, when surgery to remove their kidney (nephrectomy) is not possible. This type of cancer is called metastatic renal cell carcinoma. Axitinib has been found to help people with renal cell carcinoma who have already received previous treatment, but A-PREDICT aims to find out if axitinib can help people who have not yet had any treatment. An important part of A-PREDICT will look at biological samples donated by participants. This is to see if there is anything that will predict who axitinib treatment will work best for - at the moment very little is known about who should receive which treatment in this sort of cancer. Axitinib is a tablet, which participants will need to take twice a day. They will continue to take axitinib as long as it is helping to prevent their cancer from getting worse, and will have regular check ups at their hospital to see how they are getting on. Participants will be asked to donate samples from their cancer, and from places to which the cancer has spread (metastatic sites of disease). Samples will be taken before they start treatment, 8 weeks after starting treatment, and when they stop treatment. Because this is a very important part of the study, we will ask that people only join A-PREDICT if they think they will be willing to provide these samples, although they will be free to change their minds during the course of the study. The main aim of A-PREDICT is to find out how well axitinib controls the spread of renal cell carcinoma in the first six months of treatment.

  Results summary
  The A-PREDICT trial included 65 participants with kidney cancer which had spread throughout their body. Everyone who joined the trial was unable to have surgery to remove their kidney.
  Participants joined the trial between 2012 and 2016 from 11 NHS sites across the UK. Seven out of 10 people who joined the trial were between 50 and 70 years old. Seven out of 10 were men and nine out of 10 were white.
  Everyone who joined the study received axitinib treatment, taken as tablets twice daily. The main aim of the study was to see if taking axitinib prevented at least 4 in 10 participants’ cancer from spreading within six months after they joined the trial. We found that 38 participants’ (nearly 6 out of 10) cancer did not spread further within six months after joining the trial.
  Participants also donated samples of their cancer, which are currently being analysed to find out if axitinib worked better for people whose cancer had specific genetic abnormalities.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0639

• Date of REC Opinion

  8 May 2012

• REC opinion

  Favourable Opinion