This is a non-inferiority study in chemotherapy-naïve female patients with breast cancer, age 18 years or older, who are scheduled to receive Moderately Emetogenic Chemotherapy (MEC).
Conditions
Interventions
Trade Name: Alox®
Product Name: Palonosetron
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PALONOSETRON
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
C
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients that meet all of the following criteria may be enrolled into the study: • Willing and able to sign informed consent and complete the patient diary; • Females age =18 years; • Patients with histologically or cytologically confirmed breast cancer (BC), requiring Chemotherapy, who are naïve to chemotherapy; • Scheduled to receive of a single dose of a MEC regimen on Day 1. • Karnofsky Performance Status grade of =60 (see Appendix A); • Life-expectancy greater than 3 months; • For women of child-bearing potential, negative serum or urine pregnancy test within 2 weeks of treatment and use of physician-approved method of birth control throughout the study; • Acceptable hepatic function (=2 times the upper limit of normal [ULN]) and renal function (creatinine =1.5 times ULN). 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 palonosetron; • Known hypersensitivity reaction to any 5-HT3 receptor antagonists; • Know hypersensitivity to dexamethasone; • Prior treatment with chemotherapy; • Scheduled receipt of MEC, radiotherapy, or HEC (according to the Hesketh classification level 3 or higher) on Days 2 to 6 (see Appendix B); • Anti-emetic therapy (within 24 hours of treatment initiation) or scheduled receipt of up to Day 5) of any drug with antiemetic effects; • Nausea or vomiting with an National Cancer Institute (NCI) Common Toxicity • Symptomatic brain metastases; • Gastric outlet or intestinal obstruction; • Known current or history of drug or alcohol abuse; • Participation in another study within 30 days of (before or after) study entry. Criteria (CTC) of grade 2 or 3 in the 24 hours before receiving study medication (see Appendix C) • Ongoing vomiting from any other organic etiology • Female patients who are pregnant or breast feeding • History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: • To show that the efficacy of IV palonosetron/dexamethasone on Day 1 is noninferior to the efficacy of the same regimen on Day 1, followed by dexamethasone p.o. twice daily on Days 2 and 3, in preventing acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy (MEC); • To evaluate the safety of a single IV dose of palonosetron 0.25 mg and dexamethasone 8 mg on Day 1 followed by dexamethasone p.o. 4 mg twice daily or placebo on Days 2 and 3.;Primary end point(s): The primary efficacy endpoint for this study is: • The overall (Days 1-5) Complete Response (CR: no emesis, no rescue medication). All secondary efficacy endpoints will be evaluated during the Acute Phase, the Delayed Phase, Daily, and Overall: • Nausea (severity) scores (VAS); • Duration of nausea. • Complete Response (CR; no emesis, no rescue medication); • Complete Control (no emesis, no rescue medication, with a maximum grade of mild nausea); • Percentage of patients with no emesis; | — |
Countries
Germany, Italy, Spain
Outcome results
None listed