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

ConditionsNauseaVomitingDrug-Related Side Effects and Adverse ReactionsNeoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3537021

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

  • Standard of Care Antiemetic Therapies

    Drug

    5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

  • Background Chemotherapy

    Drug

    Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: LY3537021 + Antiemetic TherapiesExperimental treatment 3 interventions
Group B: Placebo + Antiemetic TherapiesPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV

CR defined as no vomiting and no rescue medication

Time frame
24 to 120 hours after first chemotherapy infusion

Secondary outcomes

1

Proportion of Participants with a CR to CINV

CR defined as no vomiting and no rescue medication

Time frame
Zero to 120 hours after the first chemotherapy infusion
2

Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication

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.

Time frame
Zero to 120 hours after the first chemotherapy infusion
3

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

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.

Time frame
Zero to 120 hours after the first chemotherapy infusion
4

Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021

Time frame
From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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