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| ID | Type | Description | Link |
|---|---|---|---|
| I8X-MC-JECA | Other Identifier | Eli Lilly and Company | |
| 2016-001431-12 | EudraCT Number |
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The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3200882 Schedule 1 Escalation | Experimental |
| |
| LY3200882 Schedule 2 Escalation | Experimental |
| |
| LY3200882 Schedule 1 Expansion | Experimental |
| |
| LY3200882 Schedule 2 Expansion | Experimental |
| |
| LY3200882 + LY3300054 | Experimental |
| |
| LY3200882 + Gemcitabine + nab-Paclitaxel | Experimental |
| |
| LY3200882 + Cisplatin + Radiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3200882 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) | |
| Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) | Baseline through Disease Progression or Death (estimated at up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) | |
| PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) |
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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 |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States | ||
| Weill Cornell Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34548321 | Derived | Yap TA, Vieito M, Baldini C, Sepulveda-Sanchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Lohr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D. First-In-Human Phase I Study of a Next-Generation, Oral, TGFbeta Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clin Cancer Res. 2021 Dec 15;27(24):6666-6676. doi: 10.1158/1078-0432.CCR-21-1504. Epub 2021 Sep 21. |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY3200882 in Participants With Solid Tumors | View source |
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| Japanese Arm LY3200882 | Experimental |
|
| LY3300054 | Drug | Administered intravenously |
|
| Gemcitabine | Drug | Administered intravenously |
|
| nab-Paclitaxel | Drug | Administered intravenously |
|
| Cisplatin | Drug | Administered intravenously |
|
| Intensity Modulated Radiotherapy | Radiation |
|
| ORR: Percentage of Participants with CR or PR | Baseline through Disease Progression or Death (estimated at up to 12 months) |
| Overall Survival (OS) | Baseline to Date of Death from Any Cause (estimated at up to 12 months) |
| Duration of Response (DoR) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months) |
| Progression-Free Survival (PFS) | Baseline to Disease Progression or Death (estimated at up to 12 months) |
| New York |
| New York |
| 10021 |
| United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Calvary Mater Newcastle | Newcastle | New South Wales | 2298 | Australia |
| St Vincent's Hospital Sydney | Sydney | New South Wales | 2010 | Australia |
| Greenslopes Private Hospital | Greenslopes | Queensland | 4120 | Australia |
| Princess Margaret Hospital (Ontario) | Lai Chi Kok | Kowloon | Canada |
| Hopital Saint-Louis | Paris | Cedex 10 | 75475 | France |
| CHRU de Lille | Lille | 59037 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Würzburg A. ö. R. | Würzburg | Bavaria | 97080 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 12203 | Germany |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Ospedale Policlinico Giambattista Rossi, Borgo Roma | Verona | 37134 | Italy |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C000723357 | LY3300054 |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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