Open-Label Pilot Study to Evaluate the Efficacy of Palonosetron Associated with Aprepitant (Emend) and Dexamethasone in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy (HEC) - PALO-05-01

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2005-002641-39-GB
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-10
• Study Completion: 2007-02-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified