Trial Design: This is an open-label, multi-centre, randomised, stratified, phase IIb clinical trial of ATRA administered in combination with gemcitabine and nab-paclitaxel in patients with pancreatic ductal adenocarcinoma (PDAC). Patients will be randomised to receive gemcitabine + nab-paclitaxel or gemcitabine + nab-paclitaxel + ATRA. ATRA (if allocated), gemcitabine and nab-paclitaxel will be administered in 28 day cycles. ATRA will be administered for 6 cycles whereas gemcitabine/nab-paclitaxel will be administered until disease progression. Treatment may be discontinued earlier due to unacceptable toxicities or death or because the patient requests to be withdrawn from study treatment. If treatment with gemcitabine/nab-paclitaxel is stopped prior to the patient completing 6 cycles of treatment with ATRA (if allocated), the patient may continue on treatment with ATRA alone until the 6 cycles are completed, at the discretion of the treating physician.
On completion of study treatment patients will enter a survival follow-up period for a minimum of 12 months from the date of randomisation.
This study stems from research carried out by Prof H. Kocher and his team at Barts Cancer Institute.
Chief Investigator: Prof H. Kocher
Trial contact: firstname.lastname@example.org
Sponsor: Queen Mary University of London
Participating countries: UK
Source of funding: MRC (funding), BMS (study drug)