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

Purpose

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.

Conditions

  • Nausea
  • Vomiting
  • Drug-Related Side Effects and Adverse Reactions
  • Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3537021 + Antiemetic Therapies 		Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
  • Drug: LY3537021
    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
Placebo Comparator
Placebo + Antiemetic Therapies 		Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
  • 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

Recruiting Locations

Marin Cancer Care
Greenbrae, California 94904

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618
Contact:
714-252-9415

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

BASS Cancer Center
Walnut Creek, California 94598

UCHealth Harmony
Fort Collins, Colorado 80528
Contact:
970-297-6150

Clavis Medical
Miami Lakes, Florida 33014
Contact:
786-723-4001

BRCR Global - Tamarac
Tamarac, Florida 33321
Contact:
561-477-0614

Summit Cancer Care, PC
Savannah, Georgia 31405
Contact:
912-651-5771

Hope and Healing Cancer Services
Hinsdale, Illinois 60521
Contact:
630-560-0121

North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi 38801

Laura and Isaac Perlmutter Cancer Center
New York, New York 10016

Oncology Specialists of Charlotte
Charlotte, North Carolina 28207
Contact:
704-342-1900

Southern Oncology Specialists
Huntersville, North Carolina 28078

Asante Rogue Regional Medical Center
Medford, Oregon 97504
Contact:
541-789-5003

World Research Link
Baytown, Texas 77521
Contact:
833-832-8328

John Peter Smith Hospital
Fort Worth, Texas 76104
Contact:
817-702-8049

Community Cancer Trials of Utah
Ogden, Utah 84405
Contact:
801-689-3909

Cancer Care Northwest
Spokane, Washington 99202

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com