An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Oral palonosetron; I.V. palonosetron; Dexamethasone
Intervention MeSH terms: Dexamethasone; Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of
      palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic
      drug), both given with oral dexamethasone. The objective of the study is to demonstrate that
      oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to
      prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24
      hours after administration of a single cycle of highly emetogenic chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.

          -  Diagnosed with a malignant solid tumor and scheduled to receive first course of
             cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or
             more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with
             other chemotherapeutic agents.

          -  If scheduled to receive combination regimens, non-cisplatin agents of moderate to high
             emetogenic potential are allowed and they must be administered following the cisplatin
             infusion and completed no more than 6 hours after the initiation of cisplatin
             infusion.

          -  If scheduled to receive chemotherapy agents of minimal to low emetogenic potential,
             they are to be given on Day 1 following cisplatin 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 highly emetogenic
             cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets,
             Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)

          -  If a patient has a known hepatic or renal impairment, he/she may be enrolled in this
             study at the discretion of the Investigator.

          -  If a patient has a known history or predisposition to cardiac conduction interval
             abnormalities he/she may be enrolled in this study at the discretion of the
             Investigator.

        Exclusion Criteria:

          -  If female, pregnant or lactating.

          -  Current use of illicit drugs or current evidence of alcohol abuse.

          -  Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day
             5 following cisplatin administration.

          -  Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis
             within 1 week prior to Day 1 or between Days 1 to 5.

          -  Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.

          -  Symptomatic primary or metastatic CNS malignancy.

          -  Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial
             pressure, hypercalcemia, an active infection or any uncontrolled medical conditions
             (other than malignancy) that, in the opinion of the investigator, may confound the
             results of the study, represent another potential etiology for emesis and nausea
             (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks
             in administering the study drugs to the patient.

          -  Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g.,
             palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or
             dexamethasone.

          -  Participation in a clinical trial involving palonosetron.

          -  Any investigational drugs (other than those given in this study) taken within 4 weeks
             prior to Day 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. However
             topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily
             or its equivalent are permitted.

          -  Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.

          -  Any medication with known or potential antiemetic activity within 24 hours prior to
             Day 1