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| ID | Type | Description | Link |
|---|---|---|---|
| H9H-JE-JBAP | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2157299 + Sorafenib | Experimental | LY2157299 will be administered orally twice daily for 14 days, followed by 14 days with no study drug per 28-day cycle. Sorafenib will be administered orally twice daily for 28 days, in each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2157299 | Drug | LY2157299 administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT) | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve (AUC) of LY2157299 | Cycle 1 Day1: predose through 6 hours post dose; Cycle1 Day14: predose through 24 hours post dose | |
| PK: Maximum Observed Plasma Concentration (Cmax) of LY2157299 |
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Inclusion Criteria:
Exclusion Criteria:
Are currently enrolled, or discontinued within 28 days prior to enrollment from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have undergone major surgery within 28 days prior to enrollment.
Have undergone hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, percutaneous ethanol injection, or percutaneous microwave coagulation therapy) within 28 days prior to enrollment.
Have moderate or severe cardiac disease.
Have undergone liver transplant.
Are pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 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 from 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 |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C557799 | LY-2157299 |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sorafenib |
| Drug |
Sorafenib administered orally |
|
| Cycle 1 Day 1: Predose through 6 hours post dose; Cycle 1 Day 14: Predose through 24 hours post dose |
| Time to Progression (TTP) | Baseline to objective progressive disease (estimated as 6 months) |
| Progression-free Survival (PFS) | Baseline to objective progressive disease or death (estimated as 6 months) |
| The Number of Participants with Best Response of Partial Response (PR), Complete Response (CR), Stable Disease (SD), or Progressive Disease (PD) | Baseline to objective progressive disease (estimated as 6 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 241-8515 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Suita-shi | 565-0871 | Japan |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |