J2R-MC-YAAD - A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease.

Studio Clinico

Patologia: Terapie di supporto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Linee di trattamento: Prima/N linee

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

LY35327021

Trattamento di controllo: 

LY in combination of Standard of Care

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-522204-24-00

Data di inserimento: 02.07.2026

Data di aggiornamento: 29.07.2026

Promotore

Eli Lilly and Company

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -