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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-JE-JPCQ | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + Abiraterone Acetate + Prednisolone | Experimental | Abemaciclib, abiraterone acetate and prednisolone given orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | Number of Participants with DLTs | Baseline through Cycle 1 (28 Day Cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone | PK: 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: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Kashiwa | Chiba | 277 8577 | Japan | ||
| Yokohama City University Medical Center |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D000069501 | Abiraterone Acetate |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Abiraterone Acetate | Drug | Administered orally |
|
| Prednisolone | Drug | Administered orally |
|
PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone |
| Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) |
| Yokohama |
| Kanagawa |
| 232-0024 |
| Japan |
| D011083 |
| Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |