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

JRCT ID: jRCT2041210106

Registered date:24/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 18/10/2021
• Target sample size: 350
• Countries of recruitment: Australia,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 type: Interventional

Intervention(s)

-Drug: Abemaciclib
Administered orally.
Other Name: LY2835219
-Drug: Abiraterone Acetate
Administered orally.
-Drug: Prednisone
Administered orally.
-Drug: Placebo
Administered orally.

Outcome(s)

Primary Outcome

Radiographic 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

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

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT03706365