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DISCOVER A NEW WAY TO HELP

If you are healthy and aged between 18 and 55 you can play an important part in developing a new treatment for a range of different cancers.

Inconveience Payment £5985

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called bemcentinib.

Bemcentinib is being developed for the treatment of a range of different types of cancers including solid tumour cancers (lung, breast, skin) and cancers of the blood (leukaemia).

Bemcentinib is classed as an inhibitor of the enzyme AXL kinase. An enzyme is a protein which is responsible for the control and speeding up of chemical reactions and biological processes in the body such as cell growth. AXL kinase plays a key role in the growth, survival and replication of cells.

Cancer is a condition where there is uncontrolled growth and reproduction of cells which can invade and destroy healthy tissue and blood cells in the body.

It has been identified that in a range of different cancers, there is evidence that the AXL pathway is overactive which contributes to rapid and uncontrolled growth of the cells and increased rate of spread of tumours throughout the body which leads to poorer survival rates from these types of cancers. AXL overactivity has also been associated with making certain cancers drug resistant which means that standard treatment options are not effective.

Bemcentinib has been developed to block and slow down the activity of AXL kinase to elicit more control over the AXL pathway and reduce the activity so that the growth of cells is more controlled and the spread of the cancer may be slowed. Bemcentinib has also shown to have some effect in reversing drug resistance and therefore, bemcentinib offers a promising treatment option for certain types of cancers either as a single drug or in combination with other treatments such as chemotherapy.

You will be allocated to one of 2 groups and within each group, you will be assigned randomly to complete the treatment periods in a different order. Each treatment period described below will require a different number of overnight stays.

For the treatment periods where you will either take bemcentinib following an overnight fast (fasted) or after eating a high fat meal (fed), you will be required to stay at the unit for a period of 4 days (3 overnight stays) per treatment period.

For the treatment period where you will take bemcentinib after taking esomeprazole for 6 days, you will be required to stay at the unit overnight on 2 occasions; once from Day -1 until Day 1 (1 overnight stay) and once from Day 5 until Day 7 (2 overnight stays).

If you complete this study, you will receive a maximum inconvenience payment of £5985.

study timeline

SCREENING VISIT

  • A short visit to Simbec-Orion within 28 days of the planned first dose (Day 1).

  • During this visit, assessments will be performed to determine if you are suitable to participate in the study.

TREATMENT PERIODS 1-3

  • There are 3 treatment periods for this study.

  • At each treatment period you will be required to take a dose of bemcentinib.

  • 1 treatment period will require you to take bemcentinib after an overnight fast of 10 hours (fasted), 1 treatment period will require you to take bemcentinib after eating a high fat breakfast (fed) and the other treatment period will require you to take bemcentinib after taking esomeprazole for 6 days.

  • Each dose of bemcentinib will be separated by approximately 20 days and you will complete the treatment periods in a random order.

POST STUDY FOLLOW UP VISIT

  • Approximately 5-7 days after the last blood sample in treatment period 3, you will be contacted by a member of the Simbec-Orion team.

  • During this phone call, questions will be asked to ensure that it is safe for you to be discharged from the study.

  • Once this phone call is complete, your involvement in the study is completed.

APPLY NOW

Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.

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1 Step 1

To enable us to make an assessment of your suitability for a Clinical Trial, we will first need to gather some personal details relating to your health. To ensure your suitability for a Clinical Trial, by ticking the checkbox you agree that the information you have provided is accurate to the best of your ability. Your personal data will be stored on our database which is only accessible by Simbec Research Ltd and our service providers. To aid in your suitability assessment, we will only share with companies that support us delivering our services. Under the current European Data Protection Laws (GDPR), you have a number of rights in relation to your personal data such as the right to access, right to rectification and right to be forgotten where appropriate. Please note: if you have not been contacted within 3 months of applying for a trial, please assume you are ineligible and that your data has been deleted from our system, if you believe you are eligible for another one of our trials, please apply again in 3 months.

For more information regarding our commitment to your privacy, please read our privacy policy.

Agreement

You must be between the age of 18-55 to participate in this trial. 

Your BMI must fall within the range of 18-32 kg/m2 to participate in this trial. 

1. Do you regularly use illegal drugs?(i.e. Substances that are used for non-medicinal and leisure purposes. We test as part of the medical.)
2. Have you been diagnosed with Coronavirus/COVID-19?
3. Are you registered with a GP?(must be a UK resident for at least 1 year)
4. Are you taking any prescribed or repeat medication from a GP or a chemist?
5. Do you suffer from or ever had any serious illnesses as diagnosed by your GP or health professional? (e.g. neurological, endocrinal, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic and metabolic disease)?
6. Have you taken part in a clinical trial in the last 90 days or 3 months?
7. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
8. Have you had surgery in the last 4 weeks?
9. Are you a smoker?
9.a. Have you smoked in the last 6 months or used a nicotine product in the last 6 months?
10. Have you donated Blood in the last 3 months?
11. Do you drink alcohol?
11. a. Do you consume more than 14 units a week?
12. Have you had any body piercings or tattoos in the last 6 months?:
13. Are you currently using some form of contraception?
14. Are you a vegan or vegetarian?

Thank you for your time and interest, but unfortunately based on your answer, you would be unable to participate in this trial at this time. But please feel free to fill out a general application form or keep a lookout for other clinical trials we may be recruiting for, as you may be eligible to help in a different trial

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