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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV [Срок оценки: 24 to 120 hours after first chemotherapy infusion]

Вторичные конечные точки (4)

• Proportion of Participants with a CR to CINV [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Zero to 120 hours after the first chemotherapy infusion]
• Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021 [Срок оценки: From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• 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
• … и ещё 12 центров

Turkey (Türkiye) · 9 центров

• 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
• … и ещё 1 центр

Испания · 7 центров

• 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

Австралия · 5 центров

• 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

Китай · 5 центров

• The First People's Hospital of Changde City — Changde
• Zhujiang Hospital — Гуанчжоу
• Zhejiang Provincial People's Hospital — Ханчжоу
• Jiangmen Center Hospital — Jiangmen
• The First Affiliated Hospital of Henan University of Science &Technology — Luoyang

Румыния · 5 центров

• 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

Тайвань · 5 центров

• 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

Италия · 4 центра

• Aou Ospedali Riuniti Umberto I — Ancona
• Azienda Ospedaliero Universitaria — Modena
• Azienda Ospedaliera Universitaria Pisana — Pisa
• AULSS8 Berica-Ospedale S.Bortolo — Vicenza

Япония · 4 центра

• Himeji Medical Center — Himeji
• The Cancer Institute Hospital of JFCR — Kōtoku
• Kyoto University Hospital — Kyoto
• Shizuoka Cancer Center — Nagaizumi-cho,Sunto-gun

Франция · 3 центра

• Sainte Catherine Institut du Cancer Avignon Provence — Avignon
• Centre Hospitalier d'Annecy — Epagny Metz-Tessy
• Clinique Victor Hugo Le Mans — Le Mans

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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