SPIRE
Research type
Research Study
Full title
SGI-110 to potentiate platinum response: A phase Ib/randomised IIa open label clinical trial combining SGI-110 with cisplatin and gemcitabine chemotherapy
IRAS ID
183621
Contact name
Keith Pugh
Contact email
Sponsor organisation
University Hospital Southampton NHS Trust
Eudract number
2015-004062-29
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
At present bladder cancer accounts for 10,000 new diagnoses and 5,000 deaths per annum in the UK. The current standard of care is to treat with cisplatin based chemotherapy combined with gemcitabine (GC) in both newly diagnosed and advanced disease groups. Progression or relapse following cisplatin treatment is common, however new information have suggested that DNA demethylating agents could synergise with cisplatin and in turn bypass cisplatin resistance.
SGI-110 is a DNA demethylating agent which will be added to the standard GC combination in this trial. This trial will take place in four NHS trusts in England and is looking to recruit a maximum of 56 patients.
The dose escalation phase will follow a rolling six (3+3) design in patients with advanced disease only. There will be four dose levels of SGI-110 given with the standard dose of GC. Patients will receive up to 6 cycles (each cycle lasts 21 days) of the combination chemotherapy and SGI-110. They will remain on trial until all side effects have been resolved.
Once the optimum dose has been established the trial will open in to a randomised dose expansion phase. Patients with bladder cancer who are receiving GC chemotherapy prior to planed radical cystectomy will be eligible for this part of the trial. 20 patients will be randomised to receive the combination of SGI-110 and GC or GC alone. Prior to surgery, patients will receive 3-4 cycles of GC and SGI-110 or GC alone. They will remain on trial until all side effects have been resolved.
The results will be analysed to see if there is a significant difference between the two groups and if they are positive, we will potentially open in to phase III trial.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0936
Date of REC Opinion
14 Jan 2016
REC opinion
Further Information Favourable Opinion