A trial of SRA737 for advanced cancer

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1
A trial looking at SRA737 for people with cancer that has spread or continued to grow despite other treatments (advanced cancer).
 
The first part of the trial is for people with any type of cancer apart from those of the blood such as leukaemia.
 
The next part of the trial is for people with one of 6 specific types of advanced cancer including:
  • large bowel cancer
  • ovarian cancer
  • non-small cell lung cancer (NSCLC)
  • prostate cancer
  • head and neck cancer
  • squamous cell carcinoma (SCC) of the anus

More about this trial

SRA737 (previously known as CCT245737) is a new drug that blocks substances (enzymes) in the body called checkpoint kinase 1 (CHK-1). Cells need these to repair, grow and divide. Drugs that can block these enzymes are called kinase inhibitors.
 
Researchers think that SRA737 might be able to block these enzymes and stop cancer cells from repairing and growing. This trial will be the first time SRA737 has been given to people.
 
The trial is in 2 parts. In part 1 the researchers are looking for the best dose of SRA737. This part is called dose escalation. In part 2 they are collecting information on how the drug works. This part is called the expansion cohort.
 
The main aims of the trial are to:
  • find the highest safe dose of SRA737
  • find out the side effects of SRA737
  • learn about what happens to the drug in the body
  • learn about what happens to your cancer when taking SRA737

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
You may be able to join this trial if all of the following apply. You:
  • Have satisfactory blood tests results
  • Are able to swallow and absorb capsules
  • Have a sample of your cancer available (archival tumour tissue) or are willing to have a sample of cancer taken (a biopsy) if there is no suitable sample available
  • Are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
You may be able to join the 1st part of this trial (dose escalation) if, as well as the above, you have a solid tumour (not a leukaemia) or non-Hodgkin lymphoma that has got worse despite having treatments.
 
You may be able to join the 2nd part of this trial (expansion cohort) if all of the following also apply:
  • Your cancer has certain changes (mutations). Your doctor can tell you more about this 
  • You have at least 1 area of cancer that can be seen and measured on a scan, your PSA level is increasing if you have prostate cancer, or doctors have found enough abnormal cells called circulating tumour cells (CTCs) in your bloodstream 
As well as the above, you may be able to join the 2nd part of this trial if any of the following also apply:
  • You have large bowel cancer that has spread to another part of the body (metastatic) and you have had at least 1 type of chemotherapy (chemotherapy regimens)
  • You have ovarian cancer (high grade serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer) that must have gotten worse 6 months or less after finishing treatment with a platinum type of chemotherapy 
  • You have ovarian cancer that has a change (amplification) in the CCNE1 gene, or another gene that has a similar effect. Your ovarian cancer must have gotten worse 6 months or less after finishing treatment with a platinum type of chemotherapy
  • You have non small cell lung cancer (NSCLC) that has come back or spread to another part of the body and you have had at least 1 chemotherapy regimen
  • You have prostate cancer that has spread beyond the prostate gland and has gotten worse after treatment with a type of hormone therapy called anti androgen
  • You have a squamous cell carcinoma (SCC) of the head and neck that has come back or spread to another part of the body after treatment with radiotherapy and doctors think that you can’t have surgery to try to cure your cancer. You must also have had at least 1 chemotherapy regimen
  • You have a squamous cell carcinoma (SCC) of the anus that has come back or spread to another part of the body after treatment and doctors think that you can’t have treatment to try to cure your cancer. You must also have had at least 1 chemotherapy regimen
You cannot join this trial if any of these apply:
 
Cancer related
  • You have had radiotherapy in the last 6 weeks, unless it was to control symptoms (palliative radiotherapy), or radiotherapy to more than 25% of your bone marrow in the past 8 weeks (the doctor will check for this)
  • You have had chemotherapy in the past 4 weeks (6 weeks if it was immunotherapy, the drug mitomycin C or chemotherapy from a group of drugs called nitrosoureas)
  • You have had hormone therapy in the last 4 weeks apart from luteinizing hormone for prostate cancer
  • You have had treatment with SRA737 or any similar drug in the past 6 months before having SRA737
  • You have had another cancer in the past 2 years apart from successfully treated cancers that doctors don’t expect to come back
  • You have moderate to severe side effects from previous anti-cancer treatments (apart from hair loss or other side effects your doctor thinks will not affect the trial)
  • Your cancer has spread to your brain. You might be able to take part if it hasn’t got worse in the past 8 weeks and you are taking part in the 1st part of this trial (dose escalation)
  • You have had a bone marrow transplant 
Medical conditions
  • You have had an experimental treatment in the past 4 weeks
  • You have heart problems such as congestive heart failure, an irregular heartbeat (arrhythmia) or cardiac ischaemia (a condition where your heart’s blood supply is blocked) in the past 6 months
  • You have not recovered from a major surgery
  • You have an infection that needs to be treated
  • You have HIV
  • You have hepatitis B or hepatitis C
  • You have any other serious medical condition that the trial team think could affect you taking part
Other
  • You are pregnant or breastfeeding
  • You have an allergy to peanuts

Trial design

This is a phase 1/2 trial. The researchers would like about 170 people across the UK to take part. This trial has 2 parts:
  • finding the best dose of SRA737 (dose escalation)
  • learning more about how the drug works (expansion cohort)
Everyone has SRA737. These are capsules you take every day. The dose you have depends on the part of the study you join.
 
You cannot eat for at least 2 hours before taking the capsules (but you can drink water) and you must wait at least 1 hour after having them before you eat.
 
You continue taking SRA737 for as long as the study doctor feels it is helping you and the side effects aren’t too bad.
 
People who started on a lower dose of SRA737 may be able to change to the higher dose if researchers find that the higher dose is safe.
 
Dose escalation 
The first few people taking part will have a low dose of SRA737. If they don’t have any serious side effects, the next few people have a higher dose. And so on, until doctors find the best dose.
 
Expansion cohort
The researchers need about 120 people to take part in the expansion cohort. The first few people taking part have a lower dose of SRA737 than people in the dose escalation group.
 
People may be able to have a higher dose, if the researchers find that the higher dose is safe.
 
Blood tests 
You may have some extra blood tests before you start treatment and then at set times during the trial (you may hear these tests called pharmacokinetics). The researchers want to find out what happens to SRA737 in the body.
 
Tissue sample
The trial team will also ask to use a tissue sample of your cancer taken either when you were diagnosed or during any treatment you have had. They will look for specific cancer associated gene changes in the tumour.
 
If there is not a suitable sample available the researchers might ask you to have a biopsy.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:
  • a physical examination
  • blood tests
  • urine test
  • a biopsy
  • a CT scan or MRI scan
  • an x-ray or bone scan
  • heart trace (ECG)
  • heart ultrasound (echocardiogram)
You have the first dose of SRA737 in hospital and a week later you start taking the capsules daily. You may need to stay in hospital overnight after taking the first dose of SRA737 and you will have a heart trace before and after you have the drug.
 
When you start taking the tablets daily, you go to hospital once a week for the first 3 months. You then might go to hospital every 2 weeks.
 
At each visit you see the doctor and might have:
  • a physical examination
  • blood tests
  • urine test
  • heart trace
  • a heart ultrasound if needed 
Depending on how far you live from the hospital you may need to stay overnight when you have the extra blood tests (pharmacokinetics). The trial team will explain this more. 
 
You have a CT scan or MRI scan every 8 weeks while you are having treatment. This will continue for as long as your cancer stays the same and does not get much worse. If your cancer gets worse you stop SRA737. 
 
When you finish your treatment you see the trial team:
  • 4 weeks after stopping SRA737
  • every 4 months (until you start a new anti cancer treatment or your cancer gets worse)   

Side effects

This is the first time SRA737 has been given to people so there may be side effects we don’t know about yet.
 
The trial team monitors you during the time you have treatment and you have a phone number to call them if you are worried about anything.  The team will tell you about all the possible side effects before you start the trial.
 
Researchers think the most common side effects of SRA737 are likely to be:

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.

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Questions to ask your doctor about clinical trials
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

Sierra Oncology, Inc.
Experimental Cancer Medicines Centres (ECMC)
 

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14115

Print page
Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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