Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Cisplatin Chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10054133 Term: Prophylaxis of nausea and vomiting
Conditions
Interventions
Product Name: Fosaprepitant dimeglumine
Product Code: MK-0517
Pharmaceutical Form: Intravenous infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female or male adult patients, greater than or equal 18 years of age. Patient is scheduled to receive his or her first course of cisplatin chemotherapy for a documented solid malignancy at a dose of greater than or equal 70 mg/m2. Patient has a Karnofsky score of greater than or equal 60. Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent. Please see Protocol for complete list. Are the trial subjects under 18? 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has symptomatic primary or metastatic CNS malignancy. Patient has received or is scheduled to receive radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 through Day 6. Patient has vomited in the 24 hours prior to Treatment Day 1. Patient is to receive multiple-day chemotherapy with cisplatin in a single cycle. Patient is to receive chemotherapy of moderate or high emetogenicity (per Hesketh Classification of Emetogenic Chemotherapy Agents) during the 6 days prior to the cisplatin infusion and/or during the 6 days following cisplatin infusion. Chemotherapy agents with a classification of moderate or above can be given on the same day as cisplatin, and should be given following the cisplatin infusion. There is no restriction on the timing of administration of chemotherapeutic agents of low or minimal emetogenicity except for patients receiving taxanes or pemetrexed. Please see Protocol for complete list.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen with respect to efficacy in the first cycle of cisplatin-based HEC. To evaluate the safety and tolerability of the single-dose fosaprepitant dimeglumine regimen for CINV.;Secondary Objective: To compare the single-dose fosaprepitant dimeglumine regimen and the aprepitant regimen in terms of the proportion of patients with a complete response (no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of cisplatin). See protocol for entire listing. ;Primary end point(s): Fosaprepitant dimeglumine is non-inferior to the aprepitant regimen with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) overall (in the 120 hours following initiation of cisplatin). The single-dose fosaprepitant dimeglumine regimen is well tolerated in the first cycle of cisplatin-based HEC | — |
Countries
Denmark, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden
Outcome results
None listed