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A study looking at TKI258 to treat advanced transitional cell cancer that has spread

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

This study is looking at a new drug called TKI258 to treat transitional cell cancer that has spread into the surrounding tissue (is locally advanced), or to another part of the body.

Transitional cells (also called urothelial cells) are a part of the urinary system. The urinary system filters waste products from the blood and makes urine. Transitional cells line the centre of each kidney (renal pelvis), the bladder and the tubes that drain urine from the kidneys to the bladder (ureters). So you can get transitional cell cancer in the kidney, bladder or ureters.

Doctors often treat advanced transitional cell cancer with chemotherapy. But sometimes the cancer can come back after treatment (relapsed) or continue to grow during treatment (is refractory). So they are always looking for new ways to treat advanced transitional cell cancer.

TKI258 is a type of biological therapy called a tyrosine kinase inhibitor (TKI). Tyrosine kinase is a chemical messenger (an enzyme) that sends messages to cells to tell them to grow and divide. Blocking the effect of tyrosine kinase may stop cancer cells from growing and spreading.

We know from laboratory studies that TKI258 may shrink and slow the growth of many different types of cancer.

The aims of this study are to find out

  • If TKI258 can help people with advanced transitional cell cancer
  • How safe TKI258 is to give to people with advanced transitional cell cancer

Recruitment

Start 02/06/2010
End 25/10/2011

Phase

Phase 2

Who can enter

You can enter this study if you

  • Have transitional cell cancer of the bladder, centre of the kidney (renal pelvis) or the tubes that drain urine from the kidneys to the bladder (ureters)
  • Have transitional cell cancer that is getting worse as seen on a scan
  • Have at least one tumour that can be measured on a scan and it has not been treated with radiotherapy
  • Have had one course of treatment that includes one of the following chemotherapy drugs: cisplatin, carboplatin, gemcitabine or a taxane
  • Are able to swallow capsules
  • Have satisfactory blood results
  • Are able to look after yourself and are up and about for at least half the day (performance status 0, 1, 2)
  • Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this study if you

  • Have transitional cell cancer that has spread to your brain or have symptoms that suggest it may have spread to the brain and have not had a scan to show that it hasn’t
  • Have had more than 3 courses of treatment with chemotherapy
  • Have had treatment with chemotherapy, hormone therapy or immunotherapy in the last 2 weeks
  • Have had nitrosoureas or mitomycin C in the last 6 weeks
  • Have had a biological therapy in the last 6 weeks
  • Have had radiotherapy in the last 4 weeks, or radiotherapy for control of symptoms in the last 2 weeks
  • Have had major surgery in the last 2 weeks
  • Still have side effects from any treatment you have already had for your cancer
  • Are taking a drug called warfarin to thin your blood
  • Have, or have had, a serious heart problem
  • Have a fast heart rate that is not controlled by medication
  • Have a slow heart rate
  • Have high blood pressure that is not controlled
  • Have problems with your digestion
  • Have had an abnormal collection of fluid between the sheets of skin covering the lungs (this is called pleural effusion) in the last 12 months
  • Have fluid collecting in the area between your ribs and hips (this is called ascites) that needs to be drained 2 or more times a month
  • Are known to be HIV positive
  • Have diarrhoea that cannot be controlled
  • Have any other serious medical condition that could affect you taking part in this study
  • Are pregnant or breastfeeding

Trial design

This is an international study. It will recruit about 80 people in different countries around the world.

Before taking part in the study, the researchers will ask your permission to test a sample of tissue from when you had your biopsy. This is to test for a receptor on the cancer cells called fibroblast growth factor receptor 3 (FGFR3 for short). The result of this test will determine whether or not you are able to take part in the study.

Everyone taking part in the study will have TKI258. TKI258 is a capsule. You take it for 5 days and then have 2 days of no TKI258. Your doctor will tell you how many capsules you take. You should take it about the same time each day and at least 1 hour before meals or 2 hours after a light meal.

You can continue to take TKI258 for as long as your doctor feels it is helping you and the side effects are not too bad.

Hospital visits

You will see the doctor before you start treatment and have some tests. These tests include

On the day you start treatment; you see the doctor and have the following tests

  • Physical examination
  • Heart trace (ECG)
  • Blood tests

You then see the doctor every 4 weeks and have the following tests

  • Physical examination
  • Heart trace (ECG)
  • Blood tests
  • Urine test

Every 8 weeks you have a CT scan or MRI scan, and every 12 weeks you have a heart scan (ECHO or MUGA).

After treatment you see the doctor and have the following tests

  • Physical examination
  • Heart trace (ECG)
  • Heart scan (ECHO or MUGA)
  • CT scan or MRI scan
  • Blood tests
  • Urine tests

You then see the doctor every 8 weeks and have a CT scan or MRI scan until your cancer begins to grow again.

After treatment the research team will also contact you every 8 weeks by telephone to see how you are.

Side effects

The most common side effects of TKI258 include

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr John Chester

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Novartis
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Updated: 13 April 2012