| Participants |
Inclusion criteria
signed written informed consent male or female 18 years of age or older naïve to cytotoxic chemotherapy ‐ previous biological or hormonal therapy is permitted diagnosed malignant tumour scheduled to receive repeated consecutive courses of chemotherapy ‐ a single dose of 1 or more of the following agents administered on Day 1 is allowed (see protocol) scheduled to receive combination regimens; the most emetogenic agent according to MASCC/ESMO Antiemetic Guidelines 2010 is to be given first on Day 1 and infusion must be completed within 6 h; If scheduled to receive chemotherapy agents of minimal to low emetogenic potential (Appendix 4), they are to be given on Day 1 following the most emetogenic agent, or on any subsequent study day ECOG performance status 0, 1, or 2 (Appendix 5) female patients of non‐child‐bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is postmenopausal) -
haematological and metabolic status adequate for receiving a chemotherapy regimen and fulfilment of the following criteria:
total neutrophils ≥ 1500/mm³ (standard units: ≥ 1.5 × 10⁹/L) platelets ≥ 100,000/mm³ (standard units: ≥ 100.0 × 10⁹/L) bilirubin ≤ 1.5 × ULN -
liver enzymes:
without known liver metastases, AST and/or ALT ≤ 2.5 × ULN with known liver metastases, AST and/or ALT < 5.0 × ULN serum creatinine ≤ 1.5 mg/dL (standard units: ≤ 132.6 micromol/L) or creatinine clearance ≥ 60 mL/min
able to read, understand, and follow study procedures and complete patient diary
Exclusion criteria
lactating or pregnant (i.e. positive urine dipstick pregnancy test within 24 h before Day 1 of each cycle) current use of illicit drugs or current evidence of alcohol abuse scheduled to receive i.v. cyclophosphamide (500 to 1500 mg/m²) and i.v. doxorubicin (≥ 40 mg/m²) or i.v. cyclophosphamide (500 to 1500 mg/m²) and i.v. epirubicin (≥ 60 mg/m²) scheduled to receive moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) from Day 2 to Day 5 following Day 1 chemotherapy administration active infection or uncontrolled disease except for malignancy that may pose unwarranted risk in administering study drugs to the patient known hypersensitivity or contraindication to 5‐HT₃ receptor antagonists (e.g. palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone previously received an NK₁ receptor antagonist (e.g. aprepitant, casopitant) participated in a clinical trial involving oral netupitant administered in combination with palonosetron any investigational drugs taken within 4 weeks before Day 1 Cycle 1 and/or scheduled to receive any investigational drug during the study systemic corticosteroid therapy at any dose within 72 h before Day 1 Cycle 1. However, topical and inhaled corticosteroids with a steroid dose ≤ 10 mg prednisone daily or its equivalent are permitted. Non‐study drug dexamethasone as pre‐medication in patients scheduled to receive taxanes is allowed scheduled to receive bone marrow transplantation and/or stem cell rescue therapy or any strong or moderate inhibitor of CYP3A4 or its intake within 1 week before Day 1 scheduled to receive any of the following CYP3A4 substrates: terfenadine, cisapride, astemizole, pimozide; scheduled to receive any CYP3A4 inducer or its intake within 4 weeks before Day 1 history of or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block history of risk factors for torsades de pointes (heart failure, hypokalaemia, family history of long QT syndrome) severe cardiovascular disease within 3 months before Day 1, including myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic congestive heart failure (CHF) NYHA Class III to IV, and severe uncontrolled arterial hypertension any illness or condition that, in the opinion of the investigator, may confound results of the study or pose unwarranted risk in administering investigational product to the patient concurrent medical condition that would preclude administration of dexamethasone for 4 days, such as systemic fungal infection or uncontrolled diabetes
Mean/median age, years: n.r.
Gender: male + female
Tumour/cancer type: malignant tumours
Chemotherapy regimen
HEC: cisplatin, mechlorethamine, streptozocin, cyclophosphamide ≥ 1500 mg/m², carmustine, dacarbazine
MEC: any i.v. dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, or doxorubicin; i.v. cyclophosphamide (< 1500 mg/m²), i.v. cytarabine (> 1 g/m²); azacitidine, alemtuzumab, bendamustine, or clofarabine
Countries: Bulgaria, Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Serbia, Ukraine, United States |
