None listed
Conditions
Interventions
Drug : Test drug:
Oral administration of NETU-PALO FDC (containing 300 mg netupitant and 0.5 mg palonosetron) on Day 1 (with an adjusted dexamethasone regimen: 12 mg on Day 1 + 8 mg daily from Day 2 t
Sponsors
Helsinn Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent; 2. Male or female, aged 18 years or over; 3. Cytotoxic chemotherapy naïve; 4. Have a histologically or cytologically confirmed solid tumor malignancy; 5. Be scheduled to receive the first course of cisplatin-based chemotherapy regimen (=50 mg/m2) that is to be administered over 1 to 4 hours on Day 1 (either alone or in combination with other chemotherapy agents); 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1); 7. Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures1 8. Female patients of childbearing potential2 must have a negative urine pregnancy test3); 9. Able to read, understand, and follow the study procedures and able to complete patient diary independently.
Exclusion criteria
Exclusion criteria: 1. Current use of illicit drugs or current evidence of alcohol abuse; 2. Scheduled to receive MEC or HEC from Day 2 to Day 5 following cisplatin-based chemotherapy administration; 3. Scheduled to receive bone marrow or stem cell transplant; 4. Moderately- or highly-emetogenic radiotherapy within 1 week prior to Day 1 or scheduled for study Days 1 to 5; 5. Any drug with potential antiemetic efficacy taken within 24 hours prior to Day 1; 6. Systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) other than that required by the protocol given within 72 hours prior to Day 1 (Note: topical or inhaled steroids are permitted); 7. NK1 receptor antagonists or any investigational drugs taken within 4 weeks prior to Day 1; 8. Hematologic and metabolic status inadequate for receiving a cisplatin-based HEC regimen, including any of the following criteria: a) Absolute neutrophil count 1.5 x upper limit of normal (ULN) d) Liver enzymes: In patients without known liver metastases: • aspartate aminotransferase (AST) = 2.5 x ULN • alanine aminotransferase (ALT) = 2.5 x ULN In patients with known liver metastases: • AST = 5.0 x ULN • ALT = 5.0 x ULN e) Serum creatinine = 1.5 mg/dL (standard units: =132.6 µMOL/L) f) Creatinine clearance = 50 mL/min; 9. Active infection (e.g . pneumonia) or any uncontrolled disease (e.g . diabetic ketoacidosis or gastrointestinal obstruction) that, in the opinion of the Investigator, may confound the results of the study or pose unwarranted risk in administering the study drug treatments; 10. History or predisposition to cardiac conduction abnormalities (like Torsade de Point, long QT syndrome or others), except for incomplete right bundle branch block; 11. Serious cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association [NYHA] class III-IV, see APPENDIX 5), and severe uncontrolled arterial hypertension; 12. History of any illness that, in the opinion of the Investigator, may confound the results of the study or pose unwarranted risk in administering the study treatments; 13. Any vomiting, retching, or more than mild nausea within 24 hours prior to Day 1; 14. Ongoing or recent history of somatic disease causing nausea or vomiting; 15. Symptomatic primary or metastatic central nervous system malignancy; 16. Chronic use of any CYP3A4 substrates or inhibitors (e.g . terfenadine, cisapride, astemizole, clarithromycine, ketoconazole or itraconazole) or their intake within 1 week prior to Day 1; 17. Chronic use of any CYP3A4 inducers (e.g . barbiturates, rifampicin, rifabutin, phenytoin or carbamazepine) or their intake within 4 weeks prior to Day 1; 18. Concurrent medical condition that would delay dexamethasone administration by 4 days (e.g. systemic fungal infection or uncontrolled diabetes); 19. Known contraindications to NK1 receptor antagonists, 5-HT3 receptor antagonists or dexamethasone; 20. Enrolment in a previous study with netupitant (either alone or in combination with palonosetron).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the complete response within 120 hours after the start of the administration of cisplatin-based HEC | — |
Secondary
| Measure | Time frame |
|---|---|
| CR for the 0-24 hours, 25-120 hours interval and for each 24-hour interval after the start of cisplatin-based HEC;Absence of significant nausea;Absence of nausea ;Absence of emesis;Absence of rescue medication use;Severity of nausea (measured by means of a VAS) for each 24-hour interval;Time to first emetic episode, time to first rescue medication intake, time to treatment failure ;• Impact on patients’ daily life activities in the acute and delayed phase following the administration of cisplatin-based chemotherapy | — |
Countries
Korea, Republic of
Contacts
Public ContactYounyoung Cho
Konkuk University Medical Center
Outcome results
None listed