Status:
RECRUITING
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT07169851
Start Date
November 28 2025
End Date
September 1 2026
Last Update
December 18 2025
Active Locations (67)
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1
Marin Cancer Care
Greenbrae, California, United States, 94904
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
3
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
4
BASS Cancer Center
Walnut Creek, California, United States, 94598