“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of SRA737 with gemcitabine and cisplatin or gemcitabine alone for advanced cancer
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:
More about this trial
SRA737 (previously known as CCT245737) is a new drug that blocks substances (
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.
Once researchers find the best dose, part 2 opens. In this part, they are collecting information about how the drug works. This is called dose expansion. Part 2 will be for people who have 1 of the following:
- bladder 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 (
) and the effects it has (pharmacodynamics)
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) 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
- 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 bladder 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)
- You have at least 1 area of cancer that can be seen and measured on a scan
- Your cancer has certain changes (mutations). Your doctor can tell you more about this
You cannot join this trial if any of these apply:
- 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 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
- You have had chemotherapy in the past 4 weeks (6 weeks if you had
, 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 more than 3 chemotherapy regimens after your cancer spread to other parts of your body (metastatic cancer)
- 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 had treatment with SRA737 or any similar drug 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)
- 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 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
- You are pregnant or breastfeeding
- You have an allergy to peanuts
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.
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.
Researchers need 80 people with bladder cancer, SCLC, soft tissue sarcoma, anal cancer, cervical cancer, penile cancer, vaginal cancer or vulvar cancer to take part. Everyone has the highest safe dose of SRA737 found in part 1 (dose escalation).
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.
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 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.
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)
- heart ultrasound (echocardiogram)
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)
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:
- tiredness (fatigue)
- feeling or being sick
- constipation or diarrhoea
- a drop in the number of red blood cells, white blood cells and platelets (causing an increased risk of anaemia, infection and bleeding)
We have information on gemcitabine alone.
How to join a clinical trial
Dr Udai Banerji
Sierra Oncology, Inc.
Experimental Cancer Medicines Centre (ECMC)