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| ID | Type | Description | Link |
|---|---|---|---|
| J1O-MC-JZHB | Other Identifier | Eli Lilly and Company | |
| 2018-003485-14 | EudraCT Number |
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The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3295668 Erbumine Cohort A | Experimental | LY3295668 erbumine administered orally. |
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| LY3295668 Erbumine Cohort B | Experimental | LY3295668 erbumine administered orally. |
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| LY3295668 Part JP | Experimental | LY3295668 erbumine administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3295668 Erbumine | Drug | oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Reductions | Number of Participants with Dose Reductions | Baseline through Cycle 1 (28 Day Cycle) |
| Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants who achieve CR or PR | Baseline through Measured Progressive Disease (Estimated up to 20 Months) |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine | PK: AUC of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Concentration (Cmax) of LY3295668 Erbumine | PK: Cmax of LY3295668 Erbumine | Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) |
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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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Rocky Mountain Cancer Center |
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| Label | URL |
|---|---|
| A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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BOR |
| Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) |
| Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD | DCR | Baseline through Measured Progressive Disease (Estimated up to 20 Months) |
| Denver |
| Colorado |
| 80218 |
| United States |
| H Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Levine Cancer Institute- Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78705 | United States |
| Texas Oncology Fort Worth | Fort Worth | Texas | 76104 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| US Oncology | The Woodlands | Texas | 77380 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Georges Francois Leclerc | Dijon | 21000 | France |
| Centre de Lutte Contre le Cancer Leon Berard | Lyon | 69373 | France |
| APHM Hôpital de la Timone | Marseille | 13385 | France |
| Institut Curie | Paris | 75248 | France |
| Institut de Cancérologie de l'Ouest Centre René Gauducheau | Saint-Herblain | 44805 | France |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Severance Hospital Yonsei University Health System | Seoul | Korea | 03722 | South Korea |
| Samsung Medical Center | Seoul | Korea | 06351 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp | Ankara | 06200 | Turkey (Türkiye) |
| Ege University Faculty of Medicine | Izmir | 35100 | Turkey (Türkiye) |
| Guys/St. Thomas Hospital | London | Surrey | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D004827 | Epilepsy |
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000722208 | LY3295668 erbumine |
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