A trial looking at GDC-0980 with everolimus for kidney cancer that has spread (ROVER)

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

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Closed

Phase:

Phase 2

This trial is comparing a new drug called GDC-0980 with everolimus (Afinitor) for kidney cancer that has spread to another part of the body.

The most common type of kidney cancer in adults is renal cell cancer. Doctors can treat advanced Open a glossary item kidney cancer with surgery or biological therapy.

Everolimus is a type of biological therapy that doctors use for advanced kidney cancer that has come back either during or after treatment. Everolimus stops a protein called mTOR from working properly. The mTOR protein controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus helps stop cancer growing.

GDC-0980 is also a biological therapy. We know from laboratory studies that GDC-0980 may work better at blocking mTOR than everolimus. It also blocks other proteins, such as PI3K, which also trigger cancer cells to grow.

Researchers think that GDC-0980 may be better than everolimus to treat kidney cancer that has spread. In this trial they are comparing the 2 drugs.

The aim of the trial is to find out if GDC-0980 is better than everolimus for treating kidney cancer that has spread.

Who can enter

You may be able to enter this trial if

Your hospital has stored some tissue from when you had a biopsy or surgery – if there is not a sample stored, you may be able to join if you are willing to have a biopsy and your doctor thinks it will not cause you any problems
You have renal cell cancer and a part of it is clear cell cancer
You have cancer that has spread to another part of the body
Your last treatment included a biological therapy such as sunitinib, sorafenib, pazopanib, bevacizumab, axitinib, tivozanib or a similar drug
Your cancer continued to grow while having treatment or within 6 months of stopping treatment
Your cancer can be measured on a scan
You have satisfactory blood tests results
You are able to take care of yourself, even though you may not be able to carry out all your normal daily activities (Karnofsky performance score 70 to 100)
You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have kidney cancer that has spread to your brain or spinal cord and this has not been treated
Have cancer cells in the fluid around your spinal cord – your doctor can confirm this
Have had more than 3 courses of treatment for your kidney cancer that reaches your whole body (systemic treatment )
Have had anti cancer treatment in the last 2 weeks
Have already had treatment with a drug that blocks the PI3K or mTOR proteins, such as everolimus, temsirolimus, ridaforolimus or similar drugs – your doctor can confirm this
Are still having moderate to severe side effects from any previous treatment
Take medication for high blood sugar levels
Are short of breath when resting or need oxygen to carry out your daily activities
Have low levels of oxygen in your blood when you exercise – your doctor will test for this
Have an abnormal growth of fibrous tissue in your lung (pulmonary fibrosis)
Have heart pain (angina) or heart failure
Have had a heart attack in the last 6 months
Have problems with your digestive system that could affect the way you absorb tablets
Have a liver disease such as cirrhosis
Are HIV, hepatitis B or hepatitis C positive
Have an infection that requires treatment with an antibiotic through a drip into a vein (drip )
Have an autoimmune disease such as rheumatoid arthritis that is not controlled by non steroidal anti inflammatory drugs (NSAIDs)
Are allergic to everolimus or similar drugs (or their ingredients)
Cannot swallow tablets for some reason
Have any other medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 trial. It will recruit 80 people from different countries around the world. It is a randomised trial. You will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.

People in group1 have GDC-0980
People in group 2 have everolimus

GDC-0980 is a tablet. You must take it on an empty stomach. You should not have anything to eat or drink (apart from water) for 2 hours before taking it or for 1 hour afterwards. You take it with at least half a glass of water, about the same time each day.

Everolimus is a tablet. You take it with a glass of water about the same time each day. You can take it with or without food.

You have a diary to record the date and time you take your GDC-0980 or everolimus. You can continue taking your tablets along as the side effects aren’t too bad and they are still helping you.

The trial team will also ask you to give some extra blood samples. For people having GDC-0980, they will take

4 blood samples on the day you start treatment
1 blood sample on the 2nd day of treatment
2 blood samples during week 9 of treatment

For people having everolimus, they will take 2 blood samples on the day you start treatment and 1 other sample later on in your treatment. They will use these samples to find out how GDC-0980 and everolimus work in the body.

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
Measuring the level of oxygen in your blood by putting a small device onto your finger - oxygen saturation levels
Breathing tests (lung function tests )
Heart trace (ECG )
CT scan
Urine test

During the first 2 months of treatment you see the doctor every 2 weeks and have the following tests

A physical examination
Blood tests
Measurements of the level of oxygen in your blood

You then see the doctor once a month and have the same tests. You have a CT scan every 2 months. When you finish treatment you see the doctor for the same tests and also have a heart trace. Then you see the doctor every 3 months.

The research team will continue to follow you up for the rest of your life but this can be done over the telephone.