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Recruiting Phase 2 NCT07169851

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

Phase 2 – studying effectiveness and dosage
Conditions: Nausea Vomiting Drug-Related Side Effects and Adverse Reactions Neoplasms

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg/m²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: * Have symptomatic or untreated central nervous system (CNS) metastases. * Have an established diagnosis of uncontrolled diabetes mellitus. * Have a history of, or current evidence of, a clinically significant cardiac condition or QT/QTcF-related conditions. * Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity * Signs, symptoms or history of thyroid tumors * Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy. * Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1. * Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.
Interventions
LY3537021
DRUG
Placebo
DRUG
Standard of Care Antiemetic Therapies
DRUG
Background Chemotherapy
DRUG
Locations 66
Australia (5)
Ballarat Health Services
Ballarat Central
Bendigo Health Care Group
Bendigo
WA Country Health Service Trial Centre
Perth
Goulburn Valley Health
Shepparton
Latrobe Regional Health
Traralgon
China (5)
The First People's Hospital of Changde City
Changde
Zhujiang Hospital
Guangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Jiangmen Center Hospital
Jiangmen
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang
France (4)
Sainte Catherine Institut du Cancer Avignon Provence
Avignon
NOT_YET_RECRUITING
Centre Hospitalier d'Annecy
Epagny Metz-Tessy
NOT_YET_RECRUITING
Clinique Victor Hugo Le Mans
Le Mans
NOT_YET_RECRUITING
Centre Leon Berard
Lyon Cedex08
SUSPENDED
Italy (4)
Aou Ospedali Riuniti Umberto I
Ancona
NOT_YET_RECRUITING
Azienda Ospedaliero Universitaria
Modena
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Pisana
Pisa
NOT_YET_RECRUITING
AULSS8 Berica-Ospedale S.Bortolo
Vicenza
NOT_YET_RECRUITING
Japan (4)
Himeji Medical Center
Himeji
The Cancer Institute Hospital of JFCR
Kōtoku
Kyoto University Hospital
Kyoto
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun
Romania (5)
SC Memorial Healthcare International SRL
Bucharest
NOT_YET_RECRUITING
Spitalul Clinic Colentina
Bucharest
NOT_YET_RECRUITING
Spitalul Clinic Colțea
Bucharest
NOT_YET_RECRUITING
Centrul de Oncologie "Sfântul Nectarie"
Craiova
NOT_YET_RECRUITING
Ovidius Clinical Hospital OCH
Ovidiu
NOT_YET_RECRUITING
Spain (7)
Hospital de la Santa Creu i Sant Pau
Barcelona
NOT_YET_RECRUITING
FutureMeds - Madrid
Madrid
NOT_YET_RECRUITING
Hospital General Universitario Gregorio Marañon
Madrid
NOT_YET_RECRUITING
Hospital Universitario Fundación Jiménez Díaz
Madrid
NOT_YET_RECRUITING
Hospital Universitario Virgen de la Victoria
Málaga
NOT_YET_RECRUITING
Hospital de Mataró
Mataró
NOT_YET_RECRUITING
Hospital Universitari Sant Joan de Reus
Reus
NOT_YET_RECRUITING
Taiwan (5)
E-Da Cancer Hospital
Kaohsiung City
National Cheng Kung University Hospital
Tainan
Chi Mei Hospital - Liouying Branch
Tainan
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Turkey (9)
Adana Medical Park Seyhan Hastanesi
Adana
NOT_YET_RECRUITING
Ankara Bilkent Şehir Hastanesi
Ankara
NOT_YET_RECRUITING
Antalya Egitim ve Arastırma Hastanesi
Antalya
NOT_YET_RECRUITING
Ege Universitesi Hastanesi
Bornova
NOT_YET_RECRUITING
Dicle Üniversitesi
Diyarbakır
NOT_YET_RECRUITING
Trakya University
Edirne
NOT_YET_RECRUITING
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep
NOT_YET_RECRUITING
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi
Pendik
NOT_YET_RECRUITING
Sakarya Training and Research Hospital
Sakarya
NOT_YET_RECRUITING
United States (18)
World Research Link
Baytown , Texas
Oncology Specialists of Charlotte
Charlotte , North Carolina
UCHealth Harmony
Fort Collins , Colorado
John Peter Smith Hospital
Fort Worth , Texas
Marin Cancer Care
Greenbrae , California
Hope and Healing Cancer Services
Hinsdale , Illinois
Southern Oncology Specialists
Huntersville , North Carolina
City of Hope Orange County Lennar Foundation Cancer Center
Irvine , California
NOT_YET_RECRUITING
Cancer and Blood Specialty Clinic
Los Alamitos , California
Asante Rogue Regional Medical Center
Medford , Oregon
Clavis Medical
Miami Lakes , Florida
Laura and Isaac Perlmutter Cancer Center
New York , New York
Community Cancer Trials of Utah
Ogden , Utah
Summit Cancer Care, PC
Savannah , Georgia
Cancer Care Northwest
Spokane , Washington
BRCR Global - Tamarac
Tamarac , Florida
North Mississippi Hematology and Oncology Associates
Tupelo , Mississippi
BASS Cancer Center
Walnut Creek , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.11.2025
Completion date
01.02.2027
Registry ID
NCT07169851
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.