Safety and tolerability study of 5-ALA/SFC in patients with CIA
Research type
Research Study
Full title
An Open-label, Randomized Study to Evaluate Safety, Tolerability and Pharmacokinetics of 5-ALA/SFC in Cancer Patients with Solid Tumors with Chemotherapy Induced Anemia.
IRAS ID
138304
Contact name
Christopher Twelves
Contact email
Sponsor organisation
SBI Pharmaceuticals Co., Ltd.
Eudract number
2013-002645-11
ISRCTN Number
N/A
Research summary
Anaemia is a condition with symptoms that include extreme tiredness and signs of heart failure as a result of insufficient oxygen levels in organs and other tissues. In addition to other underlying causes of anaemia, it can be a side effect of chemotherapy treatments that destroy rapidly dividing cells including cells involved in the production of red blood cells (which carry haemoglobin, which in turn carries oxygen in the blood). A reduction in red blood cells results inadequate oxygen transport throughout the body.
This Phase 2 Part 1, open-label, randomized study has been designed to obtain initial safety and pharmacokinetic data when 5-ALA/SFC is administered orally as multiple doses to selected patients with chemotherapy induced anaemia, aged 18 to 80 years old. Up to 24 patients will be randomised to one of two treatment arms: Arm 1 (18 patients) will receive 5-ALA/SFC (high dose); Arm 2 (6 patients) will receive 5-ALA/SFC (low dose). Each patient will be on study for approximately 12 weeks (including a 2 week screening period, an 8 week treatment period and up to 2 weeks follow up), a total of 8 visits.
All chemotherapy induced anaemia patients taking part in this study must have received chemotherapy within 6 weeks of the first dose of 5-ALA/SFC and are anticipated to receive a further 2 (or more) chemotherapy treatments during the study duration (between the first and last dose of 5-ALA/SFC).
Whilst 5-ALA/SFC has been shown to be safe and well tolerated in healthy volunteers, it is important to test the safety and tolerability of the study drug in a small number of patients with chemotherapy induced anaemia. This data will the support extended treatment duration and formal evaluation of effectiveness in a larger patient trial.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
13/NE/0285
Date of REC Opinion
4 Dec 2013
REC opinion
Further Information Favourable Opinion