A trial of AZD2014 with paclitaxel for solid tumours (TAX-TORC)

Cancer type:

All cancer types




Phase 1

This trial is looking at a drug called AZD2014 alongside paclitaxel. The people taking part have solid tumours Open a glossary item including ovarian cancer and a type of lung cancer called squamous cell cancer. A solid tumour is any type of cancer apart from leukaemia Open a glossary item or lymphoma Open a glossary item. The trial is supported by Cancer Research UK.

More about this trial

AZD2014 is a type of biological therapy. It works by blocking the action of a protein called mTOR which helps to control how cells grow. Cells usually divide and grow in an orderly way. But in cancer cells, proteins such as mTOR can behave abnormally and the cells grow out of control. If mTOR is blocked, this may stop or slow the growth of the cancer.

In this trial, researchers are looking at AZD2014 alongside a chemotherapy drug called paclitaxel.

The main aims of the trial are to

  • Find the highest safe dose of AZD2014 you can have with paclitaxel
  • Learn more about the side effects
  • See what happens to the drug in the body

Who can enter

You may be able to enter the 1st part of the trial if you have a solid tumour Open a glossary item that has got worse despite having other treatment, or there is no other standard treatment Open a glossary item suitable for you.

You may be able to enter the 2nd part of the trial if you have ovarian cancer, fallopian tube cancer, primary peritoneal cancer or squamous cell lung cancer that has come back despite having other treatment.

And for both parts of the trial, you must

  • Have cancer that can be measured
  • Have satisfactory blood test results
  • Be well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Be at least 18 years old
  • Be willing to use reliable contraception if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have cancer that has spread to your brain or spinal cord, or is putting pressure on your spinal cord (spinal cord compression)
  • Have had chemotherapy, hormone therapy or immunotherapy Open a glossary item in the last 3 weeks (4 weeks if you had an experimental drug and 6 weeks if you had chemotherapy drugs called nitrosoureas Open a glossary item or Mitomycin C) – you may be able to take part if you’ve been having paclitaxel (the trial team can advise you about this)
  • Have had radiotherapy in the last 3 weeks unless it was to control symptoms (palliative radiotherapy)
  • Have had radiotherapy that included more than a quarter of your bone marrow Open a glossary item in the last 8 weeks – your doctor can advise you about this
  • Have had major surgery in the last 4 weeks or minor surgery in the last 2 weeks
  • Haven’t recovered from the side effects of earlier treatment, unless they are very mild
  • Have a blockage in your bowel (bowel obstruction Open a glossary item)
  • Have any problems with your digestive system Open a glossary item that could affect how you swallow or absorb the trial drug
  • Are known to be very sensitive to paclitaxel or AZD2014 (or similar drugs)
  • Have type 1 diabetes or type 2 diabetes that is not well controlled
  • Take a drug called warfarin to thin your blood
  • Take any drugs that can affect body substances called cytochrome P (CYP) enzymes – the trial team can advise you about this (it is important that you don’t stop taking any medication without speaking to your doctor)
  • Have had a heart attack or stroke in the last year, have certain other heart problems or take other medication that can affect your heart – the trial team can advise you about this
  • Have had a bone marrow transplant
  • Have an infection that cannot be controlled, a lung condition called interstitial lung disease or serious problems with your liver or kidneys
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • Have any other condition that the trial team think would affect your taking part in this trial
  • Are taking part in another clinical trial of an experimental drug
  • Are pregnant or breastfeeding

Trial design

This phase 1 trial in 2 parts. In the 1st part of the trial, the researchers are trying to find the highest dose of AZD2014 that you can safely have alongside paclitaxel. People joining the first part of the trial can have any type of solid tumour Open a glossary item.

Everybody taking part has paclitaxel through a drip into a vein once a week. AZD2014 comes as a tablet. Some people take tablets twice a day on 3 days each week. Some people take them twice on 2 consecutive days each week.

The first few patients taking part will have a low dose of AZD2014 on 3 days each week. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study. Once the researchers have found the highest safe dose you can have on 3 days a week, there will then be a dose escalation study to find the best dose to have on 2 days a week.

You have treatment for 6 weeks and then a week without any treatment. This 7 week period is called a cycle of treatment. If the treatment is helping, you can have up to 6 cycles, which takes about 9 months.

In the 2nd part of the trial, researchers want to learn more about the combination of AZD2014 and paclitaxel. The people joining this part of the trial will have ovarian cancer, fallopian tube cancer, primary peritoneal cancer or squamous cell lung cancer that has come back after having other treatment.

In this part of the trial, some people will have AZD2014 on 3 days each week. Some people with lung cancer may have it on 2 days a week. They will have the highest safe dose for each treatment plan that was found in the 1st part of the trial. Everybody will have paclitaxel once a week.

Hospital visits

You see the trial doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood and urine tests
  • CT scan or MRI scan
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or MUGA scan Open a glossary item

The trial team will get a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item in the past. They may ask to take another biopsy before you start treatment. But you don’t have to agree to this if you don’t want to. You can still take part in the trial.

You go to hospital at least once a week to have treatment. You have regular blood tests and ECGs. You have another heart scan after the 1st cycle of treatment

The first few people taking part in the trial (the dose escalation study) have some extra blood tests in the first week of treatment. These are to see how much of each drug is in their blood and how the drugs affect the body. To have these extra tests, they stay in hospital overnight on 3 separate occasions.

If you agreed to have a biopsy before starting treatment, the researchers will ask you to have another one during the 1st cycle of treatment.

Everybody taking part has a CT or MRI scan at the end of each cycle of treatment.

When you finish treatment, you see the trial team again 4 weeks later. You have a physical examination, heart scan (ECG), blood tests and urine tests. You may have a CT or MRI scan if you haven’t had one recently.

Side effects

As AZD2014 is a new drug, there may be some side effects we don’t know about yet. The possible side effects that researchers already know about include

  • Tiredness (fatigue)
  • Rash
  • Sore mouth
  • Changes to the way your liver works
  • Feeling or being sick
  • Diarrhoea
  • Weight loss or loss of appetite
  • A change in blood sugar levels making you very thirsty or pass urine more often – the trial doctors will monitor this carefully during the trial
  • A drop in blood cells causing an increased risk of infection, tiredness and breathlessness
  • An effect on your heart – the trial team will monitor this closely and it is important to let them know if you have chest pain, breathlessness or swollen ankles

We have more information about the side effects of paclitaxel.

You mustn’t eat certain foods during the trial as they can affect how AZD2014 works. This includes grapefruit and Seville oranges.

You mustn’t use sunbeds or tanning booths during the trial and for 3 months afterwards. If you go out in the sun during this time, you must wear sunglasses and use sunscreen.



Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Udai Banerji

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKDE/12/013.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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