A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy Estudio en fase III aleatorizado, doble ciego, con control activo y de grupos paralelos, realizado en condiciones de enmascaramiento interno, para examinar la seguridad, la tolerabilidad y la eficacia de una dosis única de MK 0517 por vía intravenosa para la prevención de las náuseas y los vómitos inducidos por la quimioterapia (NVIQ) que se asocian a la quimioterapia con cisplatino - CINV Single Dose Study

Phase 1

• Conditions: Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Cisplatin Chemotherapy. Prevención de las náuseas y los vómitos inducidos por la quimioterapia (NVIQ) que se asocian a la quimioterapia con cisplatino; MedDRA version: 9.1 Level: LLT Classification code 10054133 Term: Prophylaxis of nausea and vomiting

• Registration Number: EUCTR2007-004043-30-ES
• Lead Sponsor: Merck Sharp & Dohme de España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-05
• Study Completion: 2009-06-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2292

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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.