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Recruiting NCT07169851

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

Phase II Interventional Nausea Vomiting Drug-Related Side Effects and Adverse Reactions Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY3537021, Placebo, Standard of Care Antiemetic Therapies, Background Chemotherapy.
Who it may be relevant to
Registry conditions: Nausea, Vomiting, Drug-Related Side Effects and Adverse Reactions, Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, France, Italy +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug LY3537021
    Administered SC
  • Drug Placebo
    Administered SC
  • Drug Standard of Care Antiemetic Therapies
    5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
  • Drug Background Chemotherapy
    Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Primary outcome measures

  • Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV [Time frame: 24 to 120 hours after first chemotherapy infusion]
Secondary outcome measures (4)
  • Proportion of Participants with a CR to CINV [Time frame: 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 [Time frame: 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 [Time frame: Zero to 120 hours after the first chemotherapy infusion]
  • Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021 [Time frame: From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Marin Cancer Care — Greenbrae
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine
  • Cancer and Blood Specialty Clinic — Los Alamitos
  • BASS Cancer Center — Walnut Creek
  • UCHealth Harmony — Fort Collins
  • Clavis Medical — Miami Lakes
  • BRCR Global - Tamarac — Tamarac
  • Summit Cancer Care, PC — Savannah
  • … and 12 more centers
Turkey (Türkiye) · 9 centers
  • Adana Medical Park Seyhan Hastanesi — Adana
  • Ankara Bilkent Şehir Hastanesi — Ankara
  • Antalya Egitim ve Arastırma Hastanesi — Antalya
  • Ege Universitesi Hastanesi — Bornova
  • Dicle Üniversitesi — Diyarbakır
  • Trakya University — Edirne
  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi — Gaziantep
  • T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi — Pendik
  • … and 1 more center
Spain · 7 centers
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • FutureMeds - Madrid — Madrid
  • Hospital General Universitario Gregorio Marañon — Madrid
  • Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital de Mataró — Mataró
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Hospital Universitari Sant Joan de Reus — Reus
Australia · 5 centers
  • 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 centers
  • 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
Romania · 5 centers
  • SC Memorial Healthcare International SRL — Bucharest
  • Spitalul Clinic Colentina — Bucharest
  • Spitalul Clinic Colțea — Bucharest
  • Centrul de Oncologie "Sfântul Nectarie" — Craiova
  • Ovidius Clinical Hospital OCH — Ovidiu
Taiwan · 5 centers
  • 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
Italy · 4 centers
  • Aou Ospedali Riuniti Umberto I — Ancona
  • Azienda Ospedaliero Universitaria — Modena
  • Azienda Ospedaliera Universitaria Pisana — Pisa
  • AULSS8 Berica-Ospedale S.Bortolo — Vicenza
Japan · 4 centers
  • Himeji Medical Center — Himeji
  • The Cancer Institute Hospital of JFCR — Kōtoku
  • Kyoto University Hospital — Kyoto
  • Shizuoka Cancer Center — Nagaizumi-cho,Sunto-gun
France · 3 centers
  • Sainte Catherine Institut du Cancer Avignon Provence — Avignon
  • Centre Hospitalier d'Annecy — Epagny Metz-Tessy
  • Clinique Victor Hugo Le Mans — Le Mans

Identifiers

NCT: NCT07169851 · 27402 · 2025-522204-24-00 · J2R-MC-YAAD · U1111-1322-9151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗