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
Eli Lilly and Company
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 parts are finished, which could take about 2 months.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 cli…
Interventions
- DrugLY3537021
Administered SC
- DrugPlacebo
Administered SC
- DrugStandard of Care Antiemetic Therapies
5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
- DrugBackground Chemotherapy
Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV
Locations (66)
- Marin Cancer CareGreenbrae, California
- City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
- Cancer and Blood Specialty ClinicLos Alamitos, California
- BASS Cancer CenterWalnut Creek, California
- UCHealth HarmonyFort Collins, Colorado
- Clavis MedicalMiami Lakes, Florida