A trial of SRA737 with gemcitabine and cisplatin or gemcitabine alone for advanced cancer

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1

A trial of SRA737 with gemcitabine and cisplatin or gemcitabine alone for cancer that has spread or continued to grow after treatment (advanced cancer).

It is for people with any type of cancer apart from those of the blood or lymphatic system such as:

  • leukaemia Open a glossary item
  • myeloma Open a glossary item
  • lymphoma Open a glossary item

More about this trial

SRA737 (previously known as CCT245737) is a new drug that blocks substances (enzymes Open a glossary item) in the body called checkpoint kinase 1 (CHK-1). Cells Open a glossary item need these to repair, grow and divide. Drugs that can block these enzymes are called kinase inhibitors. 

There are 2 stages in this trial. In stage 1 people had SRA737 and 2 chemotherapy drugs:

Stage 1 is now closed. So researchers are looking for people to join stage 2. In stage 2 everyone has SRA737 and gemcitabine.

Stage 2 has 2 parts. In the 1st part researchers want to find the best dose of SRA737 to give with gemcitabine. This is called dose escalation.

While researchers find the best dose, part 2 is also open. In this part, they are collecting information about how the drug works. This is called dose expansion. Part 2 is for people who have 1 of the following:

  • ovarian cancer, primary peritoneal cancer or fallopian tube cancer 
  • small cell lung cancer (SCLC)
  • soft tissue sarcoma
  • anal cancer
  • cervical cancer
  • cancer of the penis
  • vaginal cancer
  • vulvar cancer

The main aims of the trial are to:

  • find the highest safe dose of SRA737 which can be given with gemcitabine and cisplatin and gemcitabine alone
  • learn about the side effects of SRA737
  • find what happens to SRA737 in the body (pharmacokinetics Open a glossary item) and the effects it has (pharmacodynamics Open a glossary item)   

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 stage 2 of this trial if all of the following apply:

  • You have a sample of your cancer available (archival tumour tissue) or are willing to have a sample of cancer taken (a biopsy Open a glossary item) if there is no suitable sample available
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood tests results within 1 week before the start of treatment
  • You are at least 18 years old
  • You are able to swallow and absorb capsules
  • You 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 the trial (dose escalation) if all of the following also apply:

  • You have a solid tumour (not a leukaemia, myeloma or lymphoma) that has got worse despite having treatment
  • Your doctor thinks there isn’t any other suitable treatment

You may be able to join the 2nd part of this trial (dose expansion) if all of the following also apply:

  • You have ovarian cancer, primary peritoneal cancer, fallopian tube cancer, SCLC, soft tissue sarcoma, anal cancer, cervical cancer, penile cancer, vaginal cancer or vulvar cancer that has got worse despite having treatment 
  • You have had at least 1 but no more than 3 types of chemotherapy (chemotherapy regimens Open a glossary item) unless you have ovarian cancer, or are approved otherwise by the trial team
  • You have at least 1 area of cancer that can be seen and measured on a scan
  • Your cancer has certain changes (mutations) or you have a positive test for HPV Open a glossary item. This requirement is different for each cancer type.  Your doctor can tell you more about this

You cannot join this trial if any of these apply:

Cancer related

  • 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
  • You have had radiotherapy in the last 2 weeks unless it was to control your symptoms (palliative radiotherapy)
  • You have had chemotherapyimmunotherapy Open a glossary item, PARP inhibitors, other targeted therapies, or other investigational drugs in the past 2 weeks
  • You have had the drug mitomycin C or chemotherapy from a group of drugs called nitrosoureas  Open a glossary itemin the past 6 weeks
  • You have had more than 3 chemotherapy regimens after your cancer spread to other parts of your body (metastatic cancer Open a glossary item) unless you have ovarian cancer, or are approved otherwise by the trial team
  • You have had a bone marrow transplant
  • 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 at any time received treatment with SRA737 or any similar drug, or have received treatment with an ATR inhibitor in the past 6 months
  • You have had a large drop on the number of blood cells after chemotherapy (bone marrow suppression) and your doctor thinks this might happen again  
  • 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)

Medical conditions

  • 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 unless it has been approved by the trial team
  • You have had an experimental treatment in the past 4 weeks
  • You have an allergy to gemcitabine
  • 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. It has 2 stages. The researchers are no longer looking for people to join stage 1. Stage 2 is now open. The information below is about this stage.

Stage 2 has two parts:

  • finding the best dose of SRA737 which can be given with gemcitabine (dose escalation)
  • learning more about how the drug works (dose expansion)

Doctors need about 120 people to take part in stage 2.

Everyone has SRA737. These are capsules you take on set days. The dose you have depends on when you join the trial.

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.

The first time you take SRA737 you stay in hospital for 1 or 2 nights (depending how far you live from the hospital).

A week later you have gemcitabine as an intravenous (IV) drip into a vein. This takes about 30 minutes.

You have treatment over 28 days. This is called a cycle of treatment. The first day of each cycle of treatment is the day 1. You have gemcitabine on day 1, 8 and 15. And you take SRA737 for 2 days after each gemcitabine dose (days 2 and 3, days 9 and 10 and then days 16 and 17).

You continue having treatment as long as the trial 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 have a low dose of SRA737. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until doctors find the best dose.

Dose expansion

Researchers need 80 people with ovarian cancer, primary peritoneal cancer, fallopian tube cancer, SCLC, soft tissue sarcoma, anal cancer, cervical cancer, penile cancer, vaginal cancer or vulvar cancer to take part. Everyone has the same dose or a lower dose than the highest safe dose of SRA737 found in part 1 (dose escalation).

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 Open a glossary item). The researchers want to find out what happens to SRA737 in the body.

Tissue sample
The trial team will ask to use a tissue sample of your cancer taken either when you were diagnosed or during other treatments. If there is not a suitable sample available the researchers will ask you to have a biopsy.

They will look for specific gene Open a glossary item changes (mutations) that may be able to tell why treatments work better for some people than others.

Doctors might also ask you to have new tissue samples taken. You have them:

  • before the start of treatment
  • twice during the 1st treatment cycle

You do not have to agree to have new samples taken if you don’t want to. You can still take part in this trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

  • a physical examination
  • blood tests
  • urine test
  • an x-ray or bone scan
  • a CT scan or MRI scan
  • heart trace (ECG Open a glossary item)
  • heart ultrasound (echocardiogram Open a glossary item)

You might stay in hospital for 1 or 2 nights after taking the first dose of SRA737. You should not need to stay in hospital again. You have the rest of your treatment as an outpatient.

Every time you start a new cycle of treatment you see the doctor and might have:

  • a physical examination
  • blood tests
  • urine test
  • heart trace
  • echocardiogram (if needed)

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 worse. If your cancer gets worse you stop the treatment.

When you finish the treatment you see the trial team:

  • 4 weeks after stopping SRA737
  • then every 4 months (until you start a new anti cancer treatment)

Side effects

This is the first time SRA737 has been given with gemcitabine and cisplatin or gemcitabine alone 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 given in combination with gemcitabine are likely to be: 

Doctors think that SRA737 may also cause increased sensitivity to the sunlight. You should cover up or use sunscreen if you go out in the sun. 

We have information on gemcitabine alone.

Location

Cardiff
Glasgow
Leicester
London
Manchester
Newcastle upon Tyne
Oxford
Sutton
Wirral

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

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14116

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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