nausea and vomiting prevention MedDRA version: 9.1 Level: LLT Classification code 10054133 Term: Prophylaxis of nausea and vomiting
Conditions
Interventions
Trade Name: ALOXI*1FL 250MCG 5ML
Pharmaceutical Form: Solution for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Solution for
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female, age >/= 18, with colonrectal cancer or breast cancer, candidate to chemotherapy Folfox 4 or Folfiri or AC, AC-T, FEC o FAC, chemotherapy-naive, ... 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: prior treatment with chemotherapy or palonosetron,use of sperimental drug during 30 days before screening, nausea or vomiting during screening, intestinal obstruction, ...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate palonosetron in nausea/vomiting prevention in patients with breast or colon cancer, treated with moderately aemotogenic chemotherapic agents;Secondary Objective: Not specified;Primary end point(s): % of patients with complete response (no aemetic episodes and no rescue therapy) during the study | — |
Countries
Italy
Outcome results
None listed