CRAIN
Research type
Research Study
Full title
A phase 1b TiTE-CRM dose escalation clinical trial of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer
IRAS ID
1004372
Contact name
Marina Lee
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2021-006555-34
ISRCTN Number
ISRCTN18574865
Research summary
Cervical cancer affects over 3,000 women a year in the UK. Half of these women are below the age of 45 years. With current treatment, 1 in 3 women will die within 5 years. Current treatment for advanced cervical cancer combines external radiotherapy and chemotherapy (chemoradiation) followed by internal radiotherapy (brachytherapy). The chemotherapy agent used is cisplatin. The drug to be tested, tolinapant, works by blocking the activity of certain proteins that help cancer cells to survive. These proteins can cause cancer cells to die (known as apoptosis). The purpose of this study is to find the best dose of tolinapant to use with radiotherapy. This trial will also look at the side effects of this drug and ensuring that the combination is worthwhile.
Women aged 16 or over, who are scheduled to receive chemoradiotherapy treatment for cervical cancer will be approached to participate in this trial. If they provide their informed consent for the trial all patients will receive tolinapant with chemoradiotherapy. Patients will receive chemoradiotherapy as normal treatment for 5 weeks. On weeks 1, 3 and 5 they will receive tolinapant treatment taken as a tablet. This will be followed by 2 weeks of brachytherapy. The patients will then be followed up 6 weeks and 12 weeks after finishing brachytherapy treatment.
Up to 42 patients will be recruited at 6 NHS sites over a period of 24 months.
Patients will be asked to provide blood samples at each visit, these samples will look at the effects of tolinapant as well seeing if any cancer cell changes can be detected. Patients will be asked for their consent to send their pre-treatment diagnostic biopsy and to provide an additional biopsy following tolinapant and chemoradiation treatment. Patients will also undergo MRI scans with specific sequences which will be shared for research purposes, if they chose to consent to this aspect of the trial.REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0235
Date of REC Opinion
12 Aug 2022
REC opinion
Further Information Favourable Opinion