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

NCT07169851

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Nausea, Vomiting, Drug-Related Side Effects and Adverse Reactions, Neoplasms

Interventions: LY3537021, Placebo, Standard of Care Antiemetic Therapies, Background Chemotherapy

Countries: United States, Australia, China, France, Italy, Japan, Romania, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (68)
  • Greenbrae, California, United States
  • Irvine, California, United States
  • Los Alamitos, California, United States
  • Walnut Creek, California, United States
  • Fort Collins, Colorado, United States
  • Miami Lakes, Florida, United States
  • Tamarac, Florida, United States
  • Savannah, Georgia, United States
  • Hinsdale, Illinois, United States
  • Indianapolis, Indiana, United States
  • Tupelo, Mississippi, United States
  • New York, New York, United States
  • Shirley, New York, United States
  • Charlotte, North Carolina, United States
  • Huntersville, North Carolina, United States
  • Medford, Oregon, United States
  • Baytown, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Ogden, Utah, United States
  • Spokane, Washington, United States
  • Ballarat Central, Australia
  • Bendigo, Australia
  • Perth, Australia
  • Shepparton, Australia
  • Traralgon, Australia
  • Changde, China
  • Guangzhou, China
  • Hangzhou, China
  • Jiangmen, China
  • + 38 more on CT.gov