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

Phase 3

Completed

• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Interventions: Drug: aprepitant; Drug: Comparator; Placebo (unspecified)

• Registration Number: NCT00337727
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Study First Posted: 2006-06-16
• Study Start: 2007-01-01
• Primary Completion: 2008-10-28
• Study Completion: 2008-11-19
• Results First Submitted: 2009-09-30
• Results First Submitted QC: 2009-09-30
• Results First Posted: 2009-11-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 848

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Comparator; Placebo (unspecified)	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.
2	Comparator; Placebo (unspecified)	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.
1	aprepitant	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Reported No Vomiting	Overall phase (0-120 hours post initiation of MEC) in Cycle 1.	The number of patients who reported No Vomiting in the overall phase in Cycle; 1

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Reported Complete Response	Overall phase (0-120 hours post initiation of MEC) in Cycle 1	The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.