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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: Comparator: fosaprepitant dimeglumine; Drug: Comparator: ondansetron; Drug: Comparator; Placebo (unspecified); Drug: aprepitant; Drug: Comparator: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337727

0869-130

2006_016 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 848 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

848 participants in 2 patient groups

1

Other group

Description:

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.

Treatment:

Drug: Comparator: dexamethasone

Drug: Comparator; Placebo (unspecified)

Drug: aprepitant

Drug: Comparator: ondansetron

Drug: Comparator; Placebo (unspecified)

2

Other group

Description:

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.

Treatment:

Drug: Comparator: dexamethasone

Drug: Comparator; Placebo (unspecified)

Drug: Comparator: ondansetron

Drug: Comparator: fosaprepitant dimeglumine

Drug: Comparator; Placebo (unspecified)