This is a Phase 4, open-label, pilot study to evaluate the Efficacy of Plaonosetron associated with Aprepitant (Emend) and Dexamethasone in preventing nausea and vomitting in chemotherapy-naïve patients, 18 years or older receiving a Highly Emetogenic Chemotherapy (HEC) regimen containing cisplatin =70 mg/m2.
Conditions
Interventions
Trade Name: Aloxi®
Product Name: Palonosetron
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Palonosetron
Concentratio
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; • Males and females age =18 years; • Patients with histologically or cytologically confirmed malignant disease, requiring chemotherapy, who are naïve to chemotherapy; • Scheduled to receive a single dose of a HEC regimen containing cisplatin =70 mg/m2 on Day 1 (Note: cisplatin may be given in combination with other chemotherapy agents); • 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from participation in the study if they have: • Prior treatment with palonosetron; • Known hypersensitivity reaction to any 5-HT3 receptor antagonists; • Known hypersensitivity reaction to aprepitant; • Know hypersensitivity to dexamethasone; • Prior treatment with chemotherapy; • Scheduled receipt of MEC or HEC (according to the Hesketh classification level 3 or higher) on Days 2 to 6 (see Appendix B); or scheduled radiotherapy on Days 1 to 6. • 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 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; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Efficacy Parameters(s): The primary efficacy endpoint for this study is: • The overall (Days 1-5) Complete Response medication). All secondary efficacy endpoints will be evaluated during the Acute Phase, the Delayed Phase, Daily, and Overall: • Complete Response (CR; no emesis, no rescue medication); • Complete Control (no emesis, no rescue medication, mild nausea); • Percentage of patients with no emesis; Percentage • Severity of nausea (VAS); • Duration of nausea. Other secondary endpoints for evaluation also include: • The time to the first episode of emesis or use of rescue • Global Satisfaction score (VAS); • Functional Living Index-Emesis (FLIE) score; Safety Parameters Adverse events (including clinically significant laboratory (blood pressure and heart rate) will be collected. ; Main Objective: Efficacy To evaluate the efficacy of IV palonosetron when given together with p.o. aprepitant and p.o. dexamethasone on Day 1, followed by p.o. aprepitant and dexamethasone on Days 2 and 3 and p.o. dexamethasone only on Day 4 in preventing acute and delayed nausea and vomiting induced by HEC; Safety To evaluate the safety of a single IV dose of palonosetron when given together with p.o. aprepitant and dexamethasone on Day 1 followed by p.o. aprepitant and dexamethasone on Days 2 and 3 and p.o. dexamethasone only on Day 4. ;Secondary Objective: | — |
Countries
United Kingdom
Outcome results
None listed