Drug-Related Side Effects and Adverse Reactions, Nausea, Neoplasms, Vomiting
Conditions
Keywords
Chemotherapy-Induced Nausea and Vomiting (CINV), Anthracycline and cyclophosphamide (AC), Glucose-dependent Insulinotropic Peptide (GIP), Incretins, Cisplatin
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 parts are finished, which could take about 2 months.
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
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV | 24 to 120 hours after first chemotherapy infusion | CR defined as no vomiting and no rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with a CR to CINV | Zero to 120 hours after the first chemotherapy infusion | CR defined as no vomiting and no rescue medication |
| Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication | Zero to 120 hours after the first chemotherapy infusion | Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better. |
| 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 | Zero to 120 hours after the first chemotherapy infusion | Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better. |
| Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021 | From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days) | — |
Countries
Australia, China, France, Italy, Japan, Romania, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed