PCYC-1137-CA
Research type
Research Study
Full title
A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton’s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma
IRAS ID
187464
Contact name
Sarah Campbell
Contact email
Sponsor organisation
Pharmacyclics LLC
Eudract number
2015-000905-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 3 days
Research summary
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton’s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel & gemcitabine versus placebo in combination with nab-paclitaxel & gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma.
The study is composed of two parts: an open-label part, and a double-blind part. The doctor will explain to participants which phase they are being considered for.
Safety Run-In Phase
If entered in the study during the Safety Run-In Phase, participants will be given ibrutinib and nab-paclitaxel plus gemcitabine, and will not receive placebo. The reason for this is to make sure that it is safe to combine ibrutinib with nab-paclitaxel plus gemcitabine at the start of the study, before proceeding to the Double-Blind Randomisation Phase. This is necessary because these three drugs have not been studied in combination before.
Double-Blind Randomisation Phase
If entered into the double-blind randomised phase of the study, participants will be randomised to one of the two trial treatment groups. All participants will receive nab-paclitaxel and gemcitabine; in addition the assignment method is set up so that they have an equal chance of receiving ibrutinib or placebo. Neither participants nor the doctor can influence the assignment.
The placebo capsules look just like ibrutinib and are given the same way but have no active drug in them.
For all participants, treatment cycles will be 28 days long and they will receive ibrutinib or placebo daily and nab-paclitaxel and gemcitabine on Days 1, 8 and 15 of each 28-day cycle, until treatment discontinuation due to toxicity, progressive disease or maximum clinical benefit has been achieved. After the Study Doctor determines that participants qualify for enrollment in this study, they will be assigned to one of the two treatment groups.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0353
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion