Research and development services and related consultancy services

Tender description

The CRUK Cancer Trials Centre, a department of UCL, requires service to support ICON9 Clinical Trial, as fully described in Schedule 4 of this tender. The budget for this tender is 3 000 000 GBP. Suppliers that provide tender responses above this budget limited will have their offers rejected. The specification detailing UCL's full requirements is set out in Schedule 4 (Specification) and should be read before Bidders begin to respond to this ITT. Trial sponsor: UCL. Co-ordinated by: Cancer research UK & UCL Cancer Trials centre (CR UK & UCL CTC) Academic research unit funded by external charity/research grants. ICON9: An international phase III randomised study to evaluate the efficacy of maintenance cediranib and olaparib combination therapy or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy. Randomisation: 610 eligible women randomised to either cediranib + olaparib or olaparib alone (open label). Following a response (partial/complete response) to platinum based chemotherapy (4-6 cycles) for first recurrence of platinum sensitive relapsed ovarian/fallopian tube/primary peritoneal cancer, patients will be randomised to receive one of the following 2 arms: Arm 1 — Oral olaparib 300mg twice daily and cediranib 20mg once daily. The regimen may be continued beyond progression until trial closure if the patient is deemed to still be deriving clinical benefit. Arm 2 — Oral olaparib 300mg twice daily. The regimen may be continued beyond progression until trial closure if patient is deemed to still be deriving clinical benefit. IMP1: Olaparib tablets will be supplied as 100/150mg packed in high-density polyethylene (HDPE) bottles with desiccant, and have child-resistant closures. IMP2: Cediranib tablets will be supplied as 15/20mg tablets packed in high-density polyethylene (HDPE) bottles with child resistant closures. Trial Sites: — UK 35 sites recruiting ~50 % (305 women), — Australia/NZ 13/2 sites recruiting ~20 % (122 women), — Canada 10 sites recruiting ~10 % (61 women), — Italy 10 sites recruiting ~10 % (61 women), — Spain 10 sites recruiting ~10 % (61 women). There is the potential to open in one other European country if recruitment is slower than anticipated. Planned Start Date: March 2017. Recruitment Period: July 2017 for 3 years. The tenderer will be required to provide the following goods and services; on-site monitoring, database provision and Interactive web randomisation service (IWRS or IXRS).