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| ID | Type | Description | Link |
|---|---|---|---|
| I9L-MC-JZCA | Other Identifier | Eli Lilly and Company | |
| 2017-002693-39 | EudraCT Number |
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Study terminated due to strategic business decision by Eli Lilly and Company.
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The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3381916 Escalation | Experimental | LY3381916 administered orally. |
|
| LY3381916 + LY3300054 Escalation | Experimental | LY3381916 administered orally and LY3300054 administered intravenously (IV). |
|
| LY3381916 Expansion | Experimental | LY3381916 administered orally. |
|
| LY3381916 + LY3300054 Expansion B1 | Experimental | Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV. |
|
| LY3381916 + LY3300054 Expansion B2 | Experimental | Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV. |
|
| LY3381916 + LY3300054 Expansion B3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3381916 | Drug | IDO-1 inhibitor 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): Maximum Plasma Concentration (Cmax) of LY3381916 | PK: Cmax of LY3381916 | Predose Lead in Day 1 through Cycle 3 Day 1 |
| PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916 |
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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 |
|---|---|---|---|---|---|---|
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| Sarah Cannon Research Institute SCRI |
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| Label | URL |
|---|---|
| A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors | View source |
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Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV. |
|
| LY3300054 | Drug | PD-L1 inhibitor administered IV |
|
PK: AUC of LY3381916
| Predose Lead in Day 1 through Cycle 3 Day 1 |
| PK: Cmax of LY3381916 Administered in Combination with LY3300054 | PK: Cmax of LY3381916 administered in combination with LY3300054 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 |
| PK: AUC of LY3381916 Administered in Combination with LY3300054 | PK: AUC of LY3381916 administered in combination with LY3300054 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 |
| PK: Cmax of LY3300054 Administered in Combination with LY3381916 | PK: Cmax of LY3300054 administered in combination with LY3381916 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 |
| PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916 | PK: Cmin of LY3300054 administered in combination with LY3381916 | Predose Cycle 1 Day 1 through Cycle 3 Day 1 |
| Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants with a CR or PR | Baseline through Measured Progressive Disease (Estimated up to 12 Months) |
| Time to Response (TTR) | TTR | Baseline to Date of CR or PR (Estimated up to 12 Months) |
| Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR | DCR: Percentage of participants who exhibit SD, CR or PR | Baseline through Measured Progressive Disease (Estimated up to 12 Months) |
| Duration of Response (DOR) | DOR | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) |
| Progression Free Survival (PFS) | PFS | Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months) |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Finsen Institute | Copenhagen | 2100 | Denmark |
| Gustave Roussy | Villejuif | 94805 | France |
| Azienda Ospedaliera San Gerardo | Monza | Milano | 20052 | Italy |
| Azienda Ospedaliera Umberto I | Ancona | 60100 | Italy |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000723356 | IDO-1 inhibitor LY3381916 |
| C000723357 | LY3300054 |
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