NIPH Clinical Trials Search

JRCT ID: jRCT2041210106

Registered date:24/11/2021

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedProstate Cancer
Date of first enrollment18/10/2021
Target sample size350
Countries of recruitmentAustralia,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Korea,republic of,Japan,Netherlands,Japan,Romania,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
Study typeInterventional
Intervention(s)-Drug: Abemaciclib Administered orally. Other Name: LY2835219 -Drug: Abiraterone Acetate Administered orally. -Drug: Prednisone Administered orally. -Drug: Placebo Administered orally.


Primary OutcomeRadiographic Progression Free Survival (rPFS) [ Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) ] rPFS by investigator assessment
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria-Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI). -Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: -PSA progression -Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression. -Have adequate organ function. -Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclude criteria-Prior therapy with cytochrome P450 (CYP)17 inhibitors. -Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors. -Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions. -Currently enrolled in a clinical study involving an investigational product. -Gastrointestinal disorder affecting the absorption or ability to swallow large pills. -Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

Related Information


Public contact
Name Trial Guide Call Center
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name Takeshi Masaki
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
Affiliation Eli Lilly Japan K.K.