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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522204-24-00 | EU Trial (CTIS) Number | ||
| J2R-MC-YAAD | Other Identifier | Eli Lilly and Company | |
| U1111-1322-9151 | Other Identifier | World Health Organization |
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The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537021 + Antiemetic Therapies | Experimental | Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label |
|
| Placebo + Antiemetic Therapies | Placebo Comparator | Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537021 | Drug | Administered SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV | CR defined as no vomiting and no rescue medication | 24 to 120 hours after first chemotherapy infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with a CR to CINV | CR defined as no vomiting and no rescue medication | Zero to 120 hours after the first chemotherapy infusion |
| Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marin Cancer Care | Recruiting | Greenbrae | California | 94904 | United States |
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| Label | URL |
|---|---|
| A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With 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 should be approved by an independent review panel and researchers should sign a data sharing agreement.
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| Drug |
Administered SC |
|
| Standard of Care Antiemetic Therapies | Drug | 5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally |
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| Background Chemotherapy | Drug | Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV |
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Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better. |
| Zero to 120 hours after the first chemotherapy infusion |
| Proportion of Participants with a Response of Less than or Equal to (≤)3 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication | Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better. | Zero to 120 hours after the first chemotherapy infusion |
| Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021 | From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days) |
| City of Hope Orange County Lennar Foundation Cancer Center | Recruiting | Irvine | California | 92618 | United States |
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| Cancer and Blood Specialty Clinic | Recruiting | Los Alamitos | California | 90720 | United States |
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| BASS Cancer Center | Recruiting | Walnut Creek | California | 94598 | United States |
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| UCHealth Harmony | Recruiting | Fort Collins | Colorado | 80528 | United States |
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| Clavis Medical | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| BRCR Global - Tamarac | Recruiting | Tamarac | Florida | 33321 | United States |
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| Summit Cancer Care, PC | Recruiting | Savannah | Georgia | 31405 | United States |
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| Hope and Healing Cancer Services | Recruiting | Hinsdale | Illinois | 60521 | United States |
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| Indiana University Melvin and Bren Simon Cancer Center | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
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| North Mississippi Hematology and Oncology Associates | Recruiting | Tupelo | Mississippi | 38801 | United States |
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| Laura and Isaac Perlmutter Cancer Center | Recruiting | New York | New York | 10016 | United States |
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| New York Cancer and Blood Specialists | Not yet recruiting | Shirley | New York | 11967 | United States |
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| Oncology Specialists of Charlotte | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Southern Oncology Specialists | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| Asante Rogue Regional Medical Center | Recruiting | Medford | Oregon | 97504 | United States |
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| World Research Link | Recruiting | Baytown | Texas | 77521 | United States |
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| John Peter Smith Hospital | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Community Cancer Trials of Utah | Recruiting | Ogden | Utah | 84405 | United States |
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| Cancer Care Northwest | Recruiting | Spokane | Washington | 99202 | United States |
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| Ballarat Health Services | Recruiting | Ballarat Central | 3350 | Australia |
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| Bendigo Health Care Group | Recruiting | Bendigo | 3550 | Australia |
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| WA Country Health Service Trial Centre | Recruiting | Perth | 6102 | Australia |
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| Goulburn Valley Health | Recruiting | Shepparton | 3630 | Australia |
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| Latrobe Regional Health | Recruiting | Traralgon | 3844 | Australia |
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| The First People's Hospital of Changde City | Recruiting | Changde | 415003 | China |
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| Zhujiang Hospital | Recruiting | Guangzhou | 510280 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | 310014 | China |
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| Jiangmen Center Hospital | Recruiting | Jiangmen | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Recruiting | Luoyang | 471003 | China |
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| Sainte Catherine Institut du Cancer Avignon Provence | Recruiting | Avignon | 84918 | France |
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| Centre Hospitalier d'Annecy | Recruiting | Epagny Metz-Tessy | 74370 | France |
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| Clinique Victor Hugo Le Mans | Recruiting | Le Mans | 72000 | France |
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| Centre Leon Berard | Suspended | Lyon Cedex08 | 69373 | France |
| Aou Ospedali Riuniti Umberto I | Recruiting | Ancona | 60126 | Italy |
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| Azienda Ospedaliero Universitaria | Not yet recruiting | Modena | 41125 | Italy |
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| Azienda Ospedaliera Universitaria Pisana | Not yet recruiting | Pisa | 56126 | Italy |
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| AULSS8 Berica-Ospedale S.Bortolo | Not yet recruiting | Vicenza | 36100 | Italy |
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| Himeji Medical Center | Recruiting | Himeji | 670-8520 | Japan |
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| The Cancer Institute Hospital of JFCR | Recruiting | Kōtoku | 135-8550 | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
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| Shizuoka Cancer Center | Recruiting | Nagaizumi-cho,Sunto-gun | 411-8777 | Japan |
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| SC Memorial Healthcare International SRL | Recruiting | Bucharest | 013812 | Romania |
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| Spitalul Clinic Colentina | Recruiting | Bucharest | 020125 | Romania |
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| Spitalul Clinic Colțea | Recruiting | Bucharest | 030171 | Romania |
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| Centrul de Oncologie "Sfântul Nectarie" | Not yet recruiting | Craiova | 200542 | Romania |
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| Ovidius Clinical Hospital OCH | Not yet recruiting | Ovidiu | 905900 | Romania |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| FutureMeds - Madrid | Recruiting | Madrid | 28003 | Spain |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28009 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
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| Hospital de Mataró | Recruiting | Mataró | 08304 | Spain |
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| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
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| Hospital Universitari Sant Joan de Reus | Not yet recruiting | Reus | 43204 | Spain |
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| E-Da Cancer Hospital | Recruiting | Kaohsiung City | 82445 | Taiwan |
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| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
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| Chi Mei Hospital - Liouying Branch | Recruiting | Tainan | 73657 | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
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| Chang Gung Medical Foundation-Linkou Branch | Recruiting | Taoyuan | 333 | Taiwan |
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| Adana Medical Park Seyhan Hastanesi | Not yet recruiting | Adana | 01140 | Turkey (Türkiye) |
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| Ankara Bilkent Şehir Hastanesi | Not yet recruiting | Ankara | 06800 | Turkey (Türkiye) |
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| Antalya Egitim ve Arastırma Hastanesi | Recruiting | Antalya | 07100 | Turkey (Türkiye) |
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| Ege Universitesi Hastanesi | Not yet recruiting | Bornova | 35100 | Turkey (Türkiye) |
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| Dicle Üniversitesi | Recruiting | Diyarbakır | 21200 | Turkey (Türkiye) |
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| Trakya University | Recruiting | Edirne | 22030 | Turkey (Türkiye) |
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| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Not yet recruiting | Gaziantep | 27310 | Turkey (Türkiye) |
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| T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi | Recruiting | Pendik | 34899 | Turkey (Türkiye) |
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| Sakarya Training and Research Hospital | Recruiting | Sakarya | 54100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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