chemotherapy induced nausea and vomiting
Conditions
Interventions
Trade Name: IVEMEND
Product Name: IVEMEND
Product Code: MK-0517
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: FOSAPREPITANT
CAS Number: 172673-20-0
Current Sponsor c
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female = 18 years • Confirmed malignant disease • Naïve to MEC and HEC • Scheduled to receive a single IV dose of one or more MEC agents except for the combination of anthracycline and cyclophosphamide (AC MEC) such as: Alemtuzumab Daunorubicin Azacitidine Doxorubicin Bendamustine Epirubicin Carboplatin Idarubicin Clofarabine Ifosfamide Cyclophosphamide(1 g/m2) Oxaliplatin 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 740 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: • Vomiting within 24 hours of treatment day 1 • Scheduled to receive AC,cisplatin, or other HEC agent • Allergic to aprepitant, fosaprepitant, ondansetron or dexamethasone • Taking systemic corticosteroids • Known history of QT prolongation • Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, congestive heart failure, bradyarrythmia’s, pre-existing gastrointestinal conditions/gastrointestinal obstruction) except for malignancy, or a history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug/comparator to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the single-dose fosaprepitant 150 mg regimen to the control regimen in terms of the proportion of patients with Complete Response (no vomiting and no use of rescue medication) from 25 to 120 hours (delayed phase) following initiation of moderately emetogenic chemotherapy (MEC).;Secondary Objective: To compare the single-dose fosaprepitant 150 mg regimen and the control regimen in terms of the proportion of patients with a Complete Response (no vomiting and no use of rescue medication) in the overall phase (in the 120 hours following initiation of MEC).;Primary end point(s): Efficacy: The single-dose fosaprepitant 150 mg regimen provides superior control of CINV compared to the control regimen as measured by the proportion of patients with Complete Response in the delayed phase. Safety: The single-dose fosaprepitant 150 mg regimen is well tolerated in patients receiving MEC. ;Timepoint(s) of evaluation of this end point: 0 to 120 hours following initiation of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The single-dose fosaprepitant 150 mg regimen is superior to the control regimen with respect to the proportion of patients with a Complete Response in the overall phase (0in the 120 hours following initiation of MEC).;Timepoint(s) of evaluation of this end point: 0 to 120 hours following initiation of chemotherapy | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Finland, Greece, Hungary, India, Italy, Latvia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States, Venezuela, Bolivarian Republic of
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Outcome results
None listed