Description:
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.
Title
- Brief Title: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer
- Official Title: A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer
Clinical Trial IDs
- ORG STUDY ID:
17229
- SECONDARY ID:
I3Y-JE-JPCQ
- NCT ID:
NCT04071262
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Abemaciclib | LY2835219 | Abemaciclib + Abiraterone Acetate + Prednisolone |
Abiraterone Acetate | | Abemaciclib + Abiraterone Acetate + Prednisolone |
Prednisolone | | Abemaciclib + Abiraterone Acetate + Prednisolone |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Abemaciclib + Abiraterone Acetate + Prednisolone | Experimental | Abemaciclib, abiraterone acetate and prednisolone given orally. | - Abemaciclib
- Abiraterone Acetate
- Prednisolone
|
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Dose Limiting Toxicities (DLTs) |
Time Frame: | Baseline through Cycle 1 (28 Day Cycle) |
Safety Issue: | |
Description: | Number of Participants with DLTs |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: AUC of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
Measure: | PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Eli Lilly and Company |
Last Updated
June 18, 2021