My-CRA, Liquid 13 Cis Retinoic Acid
Research type
Research Study
Full title
Relative bioavailability and comparative pharmacokinetics of 13-CRA oral liquid and extracted capsule formulations: a randomised, open label, multi-dose, cross-over clinical trial in patients requiring treatment cycles of 13-CRA.
IRAS ID
220871
Contact name
Hussain Mulla
Contact email
Sponsor organisation
Nova BioPharma Limited
Eudract number
2016-005104-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
13-CRA is used to treat some children with Neuroblastoma and other cancers, usually during the maintenance phase. Currently 13-CRA is only available in gelatin capsules. So if a younger child cannot swallow capsules then there is a need to cut them open and squeeze the contents onto a spoon or into foods. Using this extraction method can result in unpredictable and variable levels of 13-CRA absorbed into the body. \n\nNova BioPharma are developing a liquid formulation of 13-CRA, to try to overcome the difficulties associated with having to cut open gelatine capsules.\n\nThis trial aims to compare the new liquid form of 13-CRA with the capsule form (currently prescribed). This trial will measure the levels of 13-CRA in the blood (pharmacokinetics) after taking 13-CRA. The trial will check that similar blood levels of 13-CRA are reached whether the patient receives it from extracted capsules or from the new liquid. This trial will provide doctors with confidence that the new liquid can be used safely in children who need 13-CRA.\n\nAt the same time we will collect information on the safety of 13-CRA use in patients for both the liquid and capsule and how easy the liquid is to use and what it tastes like by asking patients and/or parents to fill in a questionnaire.\n\nApproximately 15-20 patients, both male and female, aged 0 years to <21 years of age will be recruited. All patients requiring at least two cycles of 13–CRA therapy will be eligible. \n\nThe pharmacokinetics will be evaluated over two months. Patients will be randomised to either liquid or capsule formulation in month 1 and then then cross-over to the alternative formulation in month 2. The dose administered will be 200mg/m2/day. After the study patients will revert to standard therapy. The trial will be undertaken in approximately 8-11 NHS Trusts.\n
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0358
Date of REC Opinion
2 Jan 2018
REC opinion
Further Information Favourable Opinion