A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer
Phase 1
Completed
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT04071262
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Participant with histologically confirmed adenocarcinoma of the prostate.
- Participant with metastatic disease documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imagining (MRI).
- Participant who has serum testosterone level is ≤1.73 nanomoles per liter (nmol/L) (50 nanograms per deciliter).
- Participant who has progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy.
- Participant with adequate organ function.
- Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria
- Participant who was treated with cytochrome P450 (CYP)17 inhibitors (including abiraterone acetate, TAK-700, TOK-001, and ketoconazole).
- Participant who was treated with abemaciclib or any cyclin dependent kinase 4 and 6 (CDK4 and 6) inhibitors.
- Participant who has prior cytotoxic chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), prior radiopharmaceuticals for prostate cancer (PCa), or prior sipuleucel-T.
- Participant who has gastrointestinal disorder affecting absorption or inability to swallow large pills.
- Participant who has clinically active or chronic liver disease, moderate/severe hepatic impairment, ascites, or bleeding disorders secondary to hepatic dysfunction.
- Participant who has known or suspected central nervous system metastatic disease.
- Participant who was treated with drugs known to be strong inhibitors, or strong or moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched prior to starting study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abemaciclib + Abiraterone Acetate + Prednisolone Abiraterone Acetate Abemaciclib, abiraterone acetate and prednisolone given orally. Abemaciclib + Abiraterone Acetate + Prednisolone Abemaciclib Abemaciclib, abiraterone acetate and prednisolone given orally. Abemaciclib + Abiraterone Acetate + Prednisolone Prednisolone Abemaciclib, abiraterone acetate and prednisolone given orally.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities (DLTs) Baseline through Cycle 1 (28 Day Cycle) Number of Participants with DLTs
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) PK: AUC of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone
PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone
Trial Locations
- Locations (2)
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan