Chemotherapy-induced Nausea and Vomitting
Conditions
Interventions
Trade Name: EMEND
Product Name: Aprepitant
Product Code: MK-0869
Pharmaceutical Form: Capsule*
INN or Proposed INN: Aprepitant
Sponsors
Laboratoires Merck Sharp & Dohme-Chibret
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is at least 18 years of age Patient has histologically or cytologically confirmed malignant disease Patient is naïve to emetogenic cancer chemotherapy of moderate or high level per Hesketh. Patient is scheduled to be treated with a single dose of one of the following moderately emetogenic chemotherapy agents (given intravenously) on treatment day 1: -oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan or mitoxantrone -methotrexate (>250mg/m2) -cyclophosphamide (25mg/m2) Patient has Karnofsky score >60. See protocol for additional criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is scheduled to receive any dose of cisplatin. Patient has or will receive radiation therapy to the abdomen or pelvis in the week prior to Day 1 through Day 6. Patient has vomited in the 24 hours prior to Day 1. See protocol for additional criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: E.2.1 Main objective: 1. To demonstrate that the aprepitant regimen is superior to the control regimen with respect to the proportion of patient with no vomiting in the 120 hours following initiation of moderately emetogenic chemotherapy (MEC). 2. To demonstrate that the aprepitant regimen is non-inferior to the control regimen with respect to the proportion of patients with complete response (no vomiting and no use of rescue therapy) in the 120 hours following initiation of MEC. If non-inferiority is established the following will also be evaluated: aprepitant regimen is superior to the control regimen with respect to the proportion of patients with complete response in the 120 hours following initiation of MEC. 3. To evaluate the safety and tolerability of the aprepitant regimen for CINV. ; Secondary Objective: E.2.2 Secondary objectives: 1. To demonstrate that the aprepitant regimen is superior to the control regimen in terms of time to first vomiting episode – overall. 2. To demonstrate that the aprepitant regimen is superior to the control regimen in terms of proportion of patients with: -no vomiting (acute and delayed) -complete response (acute and delayed) -no use of rescue therapy (over, acute and delayed) -no impact on daily life (FLIE score >108) (overall) -no vomiting and no significant nausea (VAS<25mm) (overall) ; Primary end point(s): No Vomiting: in the 120 hours following initiation of MEC Complete Response (no vomiting and no use of rescue therapy): in the 120 hours following initiation of MEC | — |
Countries
France, Germany
Outcome results
None listed