None listed
Conditions
Interventions
Group 1 Type of group
Aprepitant 125mg is administered on the first day of the cycle after administration of 80mg on days 2 and 3 orally. It is repeated in the second cycle.
Group name:Group 2 Type of group
Placebo is administered orally on days 1, 2 and 3 during the first cycle and is repeated during the second cycle
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is male or female, and is> 18 years of age; • The patient suffers from a malignant disease histologically or cytologically confirmed. Note: The number of patients with breast cancer will be limited to approximately 50% of the total enrollment. • The patient is able to understand the study procedures and agrees to participate in the study by providing written informed consent. • The patient has not undergone moderate or highly emetogenic chemotherapy according to Hesketh. • The patient is scheduled to receive a single dose of one or more of the following moderately emetogenic chemotherapeutic agents on Day 1 of Treatment: Any IV dose of: oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin Cyclophosphamide IV ( lg / m2). • The patient has a predicted life expectancy> 4 months. • The patient has a Karnofsky score> 60 (see Appendix 6.4). • The patient can read, understand and complete the study questionnaires
Exclusion criteria
Exclusion criteria: • The patient suffers from a malignancy of the primary CNS or symptomatic metastasis. • The patient is scheduled to receive any dose of cisplatin. • The patient has received or will receive radiation therapy in the abdomen or pelvis in the week before the period from Day I to Day 6 of the Treatment. • The patient has vomited in the 24 hours prior to Day 1 of the Treatment. • The patient has a history of treatment with moderate or high emetogenic chemotherapy according to Hesketh • The patient has an active infection (for example, pneumonia) or any uncontrolled disease (for example, diabetic ketoacidosis, gastrointestinal obstruction) with the exception of a malignancy that, in the opinion of the researcher, could confuse the results of the study or represent a unjustified risk. • The patient currently consumes any illicit drug, such as marijuana, or presents current evidence of alcohol abuse, as determined by the investigator. • The patient is mentally impaired or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, prevents them from entering the study. • The patient has a history of a disease that, in the opinion of the investigator, could confuse the results of the study or represent an unjustified risk. • The patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone • The patient is pregnant or breastfeeding. (Potentially fertile patients are required to show a negative urine pregnancy test before entering the study). • The patient has participated in a study with aprepitant or has taken an unapproved (investigational) pill within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:which is defined as without vomiting and without the use of rescue therapy during the entire period of time (from 0 to 120 hours) after the start of the MEC. Measure:proportion of patients reporting without vomiting and the proportion of patients reporting Complete Response Timepoints:120 hours after the start of the MEC | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of patients Without use of a Rescue Therapy in general - Acute and Late. No Impact on Daily Life (total score FLIE> 108) -In General. No Vomiting and No Significant Nausea (VAS 108) -In General. No Vomiting and No Significant Nausea (VAS <25 mm) - In General. Timepoints:During the study ; Outcome name:with respect to the proportion of patients with Complete Response (Without Vomiting and without the use of rescue therapy) in General (in the 120 hours after the beginning of MEC). Measure:The time elapsed until the first episode of vomiting in general. Timepoints:in the 120 hours after the beginning of MEC ; Outcome name:The following information collected during Cycle 1 will be evaluated through statistical and clinical review: adverse events (AD), reasons for discontinuation due to AD, vital signs, physical exams, laboratory values, and ECG. Measure:Safety and tolerability Timepoints:During the study | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed