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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
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
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
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
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
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)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV
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