None listed
Conditions
Interventions
Group 1 Type of group
Day 1: 375 mg of MK-0869 orally + 32 mg of ondansetron intravenously + 20 mg of dexamethasone orally.
Days 2-5: 250 mg of MK-0869 orally + 8 mg dexamethasone orally once daily
Group name:Group 3 Type of group
Day 1: Placebo + 32 mg of ondansetron intravenously + 20 mg of dexamethasone orally.
Days 2-5: 8 mg dexamethasone orally once daily
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is an adult with an age of> 18 years. • The patient is expected to receive his first series of cisplatin chemotherapy for a histologically documented solid tumor at a dose of> 70 mg / m ^ 2 administered in 60 (Appendix 1) and has an expected life expectancy of> 3 months. • The patient is able to understand and complete the questionnaires and the study diary, including questions that require an answer according to the visual analog scale (VAS). • The patient understands the procedures and agrees to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: • The patient is mentally incapacitated or has an important emotional or psychiatric disorder that, in the opinion of the researcher, prevents his admission to the study. • The patient currently uses illicit drugs or there is current evidence of alcohol consumption determined by the investigator. • The patient is undergoing treatment for epilepsy. • The patient has received an unauthorized drug in the last 4 weeks. • Abnormal laboratory values • The patient has a history of diseases that, in the opinion of the researcher, could confuse the results of the study or represent an unjustified risk when administering the study drug to the patient. • The patient has an active infection (for example, pneumonia) or any uncontrolled disease (for example, diabetic ketoacidosis, gastrointestinal obstruction) except for a tumor that in the opinion of the investigator could confuse the results of the study or represent an unjustified risk when administering the Study drug to the patient. • The patient will receive a multi-day chemotherapy with cisplatin in a single cycle. • The patient will receive a chemotherapy of moderate or high emetogenicity (Hesketh Level 3 or higher; Appendix 2) on the day (s) before and / or after the day the cisplatin infusion is performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete Response: No emetic episode and no rescue therapy (excludes patients receiving rescue therapy). Measure:Complete Response Timepoints:from the start of the infusion of cisplatin (Day 1) until the morning of Day 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:An emetic episode is defined as one or more continuous vomiting (expulsion of gastric contents through the mouth) or arcades (an attempt to vomit that does not generate gastric contents). The different emetic episodes are, by definition, separated by the absence of vomiting and retching for at least 1 minute. The patient will record the time (time and date) and number of emetic episodes in the diary at the time of the occurrence. Measure:Absence of emesis Timepoints:During the study ; Outcome name:Total Control: No emetic episode, no rescue therapy and absence of nausea (VAS <5 mm). The definition of a VAS score of <5 mm as absence of nausea is obtained from studies that led to the recent approval of the 5 HT3 antagonist, dolasetron. Measure:Number of patients in Total Control Timepoints:During the study ; Outcome name:The definition of a VAS score of <5 mm as absence of nausea is obtained from studies that led to the recent approval of the 5 HT3 antagonist, dolasetron. Measure:Evaluation of the severity of nausea by the patient using the VAS. Timepoints:During the study | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed