Abiraterone Acetate + Prednisone with Abemaciclib or placebo for mCRPC
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
IRAS ID
253030
Contact name
Ursula McGovern
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2016-004276-21
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
Prostate cancer (PCa) is a leading cause of mortality and morbidity globally, with more than 1 million cases diagnosed and over 300,000 deaths annually. PCa is the second most common diagnosed malignancy and the fifth leading cause of cancer mortality in men, representing a substantial public health burden. Although most patients with metastatic disease initially respond to conventional androgen deprivation therapy (ADT), inevitably, the disease progresses to metastatic castration-resistant prostate cancer (mCRPC). Although several new agents changed the therapeutic landscape of mCRPC, it is a deadly disease and a need remains for effective agents that can improve and maintain the quality and duration of life while preventing the morbidity associated with disease progression.
Abemaciclib (Verzenio® [LY2835219]) is an oral drug that blocks the cell cycle by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), two drivers of cell division. Based positive phase 2 and 3 clinical trial results, abemaciclib is currently FDA approved for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (mBC), alone or in combination with hormone therapy.
Similar to breast cancer, the CDK4 and CDK6 inhibitors show preclinical anti tumor activity in prostate cancer cell models. Study JPCM is a Phase 2, multicenter, multinational, randomised, double-blind, placebo-controlled study designed to evaluate whether the addition of abemaciclib to abiraterone acetate plus prednisone (an approved treatment for mCRPC) improves patient outcomes and assess the safety and tolerability of the drug combination. The study will be conducted in 2 parts, part 1 will determine the abemaciclib dose for further clinical investigation, and part 2 will assess the safety and anti-tumor activity of the combination.
The patient population includes male patients ≥18 years old with a diagnosis of confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology. The patient must have metastatic PCa documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) and progressive disease at study entry demonstrated during continuous androgen deprivation therapy/post orchiectomy. Other inclusion/exclusion criteria apply.
Approximately 180 participants from the US, EU, Korea and Australia will be selected to take part, with 12 participants from the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1882
Date of REC Opinion
11 Feb 2019
REC opinion
Further Information Favourable Opinion