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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

Conditions
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Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
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* Drug: aprepitant
* Drug: Comparator: ondansetron
* Drug: Comparator: dexamethasone
* Drug: Comparator: fosaprepitant dimeglumine
* Drug: Comparator; Placebo (unspecified)
* Drug: Comparator; Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. | Drug: aprepitant<br>* aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.<br>* Other names: MK0869;Drug: Comparator: ondansetron<br>* Ondansetron 8 mg capsule Three day treatment period.<br>* Other names: Zofran®;Drug: Comparator: dexamethasone<br>* dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.<br>* Other names: DEXAMETHASONE TABLETS USP;Drug: Comparator; Placebo (unspecified)<br>* dexamethasone 12mg Pbo tablets.<br>|
| Other: 2<br>Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1. | Drug: Comparator: ondansetron<br>* Ondansetron 8 mg capsule Three day treatment period.<br>* Other names: Zofran®;Drug: Comparator: dexamethasone<br>* dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.<br>* Other names: DEXAMETHASONE TABLETS USP;Drug: Comparator: fosaprepitant dimeglumine<br>* fosaprepitant dimeglumine 115 mg<br>* Other names: EMEND®;Drug: Comparator; Placebo (unspecified)<br>* Aprepitant 80 mg & 125 mg Pbo capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Reported No Vomiting | The number of patients who reported No Vomiting in the overall phase in Cycle 1 | Overall phase (0-120 hours post initiation of MEC) in Cycle 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Overall phase (0-120 hours post initiation of MEC) in Cycle 1 |