JPCJ: Abemaciclib in Metastatic Pancreatic Ductal Adenocarcinoma
Research type
Research Study
Full title
An Adaptive Open-label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
IRAS ID
212247
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-002218-36
Duration of Study in the UK
2 years, 4 months, 24 days
Research summary
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal solid cancers. Due to a lack of clinical symptoms, PDAC is diagnosed when the cancer has reached an advanced stage and metastasised, that is, the cancer has spread to other parts of the body. Despite advances in first- and second-line therapies, overall survival remains poor, and novel therapies are urgently needed.
Cyclin-dependent kinases (CDK) are a family of proteins that regulate cell growth. When two members of this family (CDK4 and 6) become altered, cancer growth can be more aggressive. Abemaciclib is a selective and potent inhibitor of CDK4/6, and has been shown to significantly slow down tumour growth in multiple animal models of human cancer, as well as resulting in a decrease in tumour size in patients with a certain type of breast cancer.
The aim of this study is to determine if abemaciclib is safe and effective in patients with metastatic PDAC who have had at least one but not more than two prior therapies. There will be four treatment groups A, B, C and D. Participants will receive abemaciclib therapy on its own (Group A) or in combination with two other investigational anti-cancer therapies (Groups B and C), or will only receive standard of care treatment (Group D) with either capecitabine or gemcitabine, depending on the participant’s previous treatment.
This is an open-label, randomised study, meaning that both the participants and the study doctor will know which treatment is being given and participants will be randomly allocated to each treatment group.
Study assessments will include physical examinations, questionnaire completion, blood tests and radiological scans. Participants will be able to remain in the study for as long as they are benefitting from the study treatment.
Eli Lilly is sponsoring this study, which is expected to recruit 240 participants worldwide, with 27 participants in the U.K.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0024
Date of REC Opinion
17 Feb 2017
REC opinion
Further Information Favourable Opinion