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| ID | Type | Description | Link |
|---|---|---|---|
| I6A-JE-CBBH | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3023414 | Experimental | LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3023414 | Drug | LY3023414 administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT) | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414 | Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414 | Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.) |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Chiba | 277 8577 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000621566 | LY3023414 |
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| Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) | Baseline through study completion (estimated as up to five months) |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Tokyo | 104-0045, | Japan |