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| ID | Type | Description | Link |
|---|---|---|---|
| J1O-MC-JZHC | Other Identifier | Eli Lilly and Company | |
| 2018-004183-61 | EudraCT Number |
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The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3295668 Erbumine Part A | Experimental | LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
|
| LY3295668 Erbumine Part B | Experimental | LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
|
| LY3295668 Erbumine + Endocrine Therapy Cohort 1 | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II). |
|
| LY3295668 Erbumine + Endocrine Therapy Continuation Part C | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). |
|
| LY3295668 Erbumine + Endocrine Therapy Switch Part D | Experimental | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3295668 Erbumine | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Reductions | Number of Participants with Dose Reductions | Baseline through Cycle 1 (28 Day Cycle) |
| Part II: Number of Participants with Dose Limiting Toxicities (DLTs) | Part II: Number of Participants with DLTs | Baseline through Cycle 1 (28 Day Cycle) |
| Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | ORR | Baseline through Measured Progressive Disease (Estimated up to 23 Months) |
| Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months | CBR | Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months) |
| Progression-Free Survival (PFS) |
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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 |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-0269 | United States | ||
| Dana Farber Cancer Institute |
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| Label | URL |
|---|---|
| A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body | View source |
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|
| Endocrine therapy | Drug | Administered according to label instructions. |
|
| Midazolam | Drug | Administered orally. |
|
PFS
| Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months) |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 | PK: AUC of LY3295668 | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| PK: AUC of LY3295668 in Combination with Endocrine Therapy | PK: AUC of LY3295668 in Combination with Endocrine Therapy | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| PK: AUC of Endocrine Therapy in Combination with LY3295668 | PK: AUC of Endocrine Therapy in Combination with LY3295668 | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| PK: AUC of Midazolam | PK: AUC of Midazolam | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| PK: AUC of Midazolam in Combination with LY3295668 | PK: AUC of Midazolam in Combination with LY3295668 | Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229-3307 | United States |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000722208 | LY3295668 erbumine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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