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| ID | Type | Description | Link |
|---|---|---|---|
| J1O-MC-JZHD | Other Identifier | Eli Lilly and Company | |
| 2019-001042-18 | EudraCT Number | ||
| 2019-01 | Other Identifier | NANT | |
| ITCC-085 | Other Identifier | ITCC |
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| Name | Class |
|---|---|
| New Approaches to Neuroblastoma Therapy Consortium | OTHER |
| Innovative Therapies for Children with Cancer in Europe (ITCC) | UNKNOWN |
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The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3295668 Erbumine Escalation | Experimental | LY3295668 Erbumine given orally. |
|
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation | Experimental | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). |
|
| LY3295668 Erbumine Expansion | Experimental | LY3295668 Erbumine given orally. |
|
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion | Experimental | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3295668 Erbumine | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | Number of Participants with DLTs | Baseline through Cycle 2 (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 5 Years) |
| Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 | PK: AUC of LY3295668 | Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
| PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide |
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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 |
|---|---|---|---|---|---|---|
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | United States | ||
| Children's Hospital Colorado |
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| Label | URL |
|---|---|
| A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma | View source |
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| Topotecan | Drug | Administered IV. |
|
| Cyclophosphamide | Drug | Administered IV. |
|
PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide
| Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles) |
| Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) | BOR | Baseline to Date of Objective Disease Progression (Estimated up to 5 Years) |
| Progression-Free Survival (PFS) | PFS | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years) |
| Overall Survival (OS) | OS | Baseline to Date of Death from Any Cause (Estimated up to 6 Years) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Chicago - Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Childrens Hospital | Houston | Texas | 77030 | United States |
| Perth Children's Hospital | Perth | Western Australia | 6009 | Australia |
| UZ Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69373 CEDEX 08 | France |
| Institut Curie | Paris | 75248 | France |
| Universitätsklinikum Köln | Cologne | 50924 | Germany |
| Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 8035 | Spain |
| Hospital Infantil Universitario Niño Jesús | Madrid | 28009 | Spain |
| Alder Hey Children's Hospital | Liverpool | L14 5AB | United Kingdom |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000722208 | LY3295668 erbumine |
| D019772 | Topotecan |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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