Clinical trial NCT01376297 (phase 3, status: completed)
Conditions: chemotherapy-induced nausea and vomiting
ICD codes: D61.810
Drugs: netupitant and palonosetron, aprepitant, palonosetron, dexamethasone
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Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent.

          -  Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.

          -  Diagnosed with a malignant tumor.

          -  If scheduled to receive repeated consecutive courses of chemotherapy, a single dose of
             one or more of the following agents administered on Day 1 is allowed:

               -  Highly emetogenic chemotherapy: any I.V. dose of cisplatin, mechlorethamine,
                  streptozocin, cyclophosphamide more or equal to 1500 mg/m2, carmustine,
                  dacarbazine;

               -  Moderately emetogenic chemotherapy: any I.V. dose of oxaliplatin, carboplatin,
                  epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin,
                  cyclophosphamide I.V. (less than 1500 mg/m2), cytarabine I.V. (more than 1 g/m2),
                  azacidine, alemtuzumab, bendamustine, or clofarabine.

          -  If scheduled to receive combination regimens, the most emetogenic agent is to be given
             as first on Day 1 and the infusion must be completed within 6 hours.

          -  If scheduled to receive chemotherapy agents of minimal to low emetogenic potential,
             they are to be given on Day 1 following the most emetogenic agent or on any subsequent
             study day.

          -  ECOG Performance Status of 0, 1, or 2

          -  Female patients of either non-childbearing potential or child-bearing potential with a
             commitment to use contraceptive methods throughout the clinical trial

          -  Hematologic and metabolic status adequate for receiving a moderately emetogenic
             regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver
             enzymes, Serum Creatinine or Creatinine Clearance)

        Exclusion Criteria:

          -  If female, lactating or pregnant

          -  Current use of illicit drugs or current evidence of alcohol abuse.

          -  Scheduled to receive either cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V.
             doxorubicin (more or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2)
             and I.V. epirubicin (more or equal to 60 mg/m2).

          -  Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 to Day 5
             following Day 1 chemotherapy administration.

          -  Active infection or uncontrolled disease except for malignancy that may pose
             unwarranted risks in administering the study drugs to the patient.

          -  Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or
             dexamethasone.

          -  Previously received an NK1 receptor antagonist

          -  Participation in a clinical trial involving oral netupitant administered in
             combination with palonosetron.

          -  Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is
             scheduled to receive any investigational drug during the study.

          -  Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1.
             Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg of
             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.

          -  Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within 1
             week prior to 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 prior to Day 1

          -  History or predisposition to cardiac conduction abnormalities, except for incomplete
             right bundle branch block.

          -  History of risk factors for Torsade de Point (heart failure, hypokalemia, family
             history of Long QT Syndrome).

          -  Severe cardiovascular diseases within 3 months prior to Day 1, including myocardial
             infarction, unstable angina pectoris, significant valvular or pericardial disease,
             history of ventricular tachycardia, symptomatic Congestive Heart Failure and severe
             uncontrolled arterial hypertension.

          -  Any illness or condition that, in the opinion of the investigator, may confound the
             results of the study or pose unwarranted risks in administering the 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.