Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

Merck Sharp & Dohme LLC848 enrolled

Overview

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

848

Conditions

Chemotherapy-Induced Nausea and Vomiting

Interventions

aprepitantDRUG

aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.

Comparator: ondansetronDRUG

Ondansetron 8 mg capsule Three day treatment period.

Comparator: dexamethasoneDRUG

dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1 * Karnofsky score of 60 or greater Exclusion Criteria: * Patient is scheduled to receive any dose of cisplatin * Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy * Any allergies to study drug or antiemetics * Taking CYP3A4 substrates/prohibited medication * Significant medical or mental conditions * Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).

Outcomes

Primary Outcomes

Number of Patients Who Reported No Vomiting

The number of patients who reported No Vomiting in the overall phase in Cycle 1

Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

Secondary Outcomes

Number of Patients Who Reported Complete Response

The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.

Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1

Data from ClinicalTrials.gov

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