A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)
Condition: Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
MeSH terms: Nausea; Vomiting
Intervention: palonesetron
Intervention description: One dose administered intravenously 30 minutes pre-chemotherapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LEC; Low Emetogenic Chemotherapy; Nausea and Vomiting; Nausea; Vomiting; Anti- emetic

Summary:

      This study is designed to assess the safety and efficacy of palonesetron in preventing
      chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have
      experienced either vomiting and or at least moderate nausea during their last cycle of low
      emetogenic chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria

        In order to be eligible for enrollment, subjects must meet the following inclusion
        criteria:

          1. Provide written informed consent

          2. Male or female ≥18 years of age

          3. Histologically or cytologically confirmed malignant disease

          4. Karnofsky Index of 50%

          5. Experienced either vomiting and/or at least moderate nausea during their last cycle of
             LEC

          6. Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC
             agents listed in the protocol.

          7. Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at
             the discretion of the Investigator Exclusion Criteria

        Subjects who meet any of the following criteria will be excluded from this study:

          1. Inability or unwillingness to understand or cooperate with the study procedures as
             determined by the Investigator

          2. Women who are pregnant, nursing or planning to become pregnant, women of childbearing
             potential who are not using an effective method of pregnancy prevention (including
             implants, injectables, combined oral contraceptives, some intrauterine devices,
             vasectomized partner or sexual abstinence), or women who have had a positive serum
             pregnancy test at screening or within 7 days prior to receiving chemo on Day 1.
             Non-childbearing potential includes women who are post-menopausal (12 months of
             amenorrhea with no other demonstrable cause, in the appropriate age group) or
             documented surgical sterilization, or hysterectomy at least 3 months before study
             start.

          3. Previous use of palonosetron in association with a LEC regimen

          4. Received more than one antiemetic agent for prevention of CINV (Chemotherapy-Induced
             Nausea and Vomiting) during their last cycle of LEC (other than dexamethasone or
             prednisone as outlined in number 7 below). The use of an antiemetic in addition to a
             corticosteroid during the last cycle of LEC is allowed if the corticosteroid is
             intended for the prophylactic treatment of taxane-related hypersensitivity or
             pemetrexed-related skin reactions as long as the corticosteroid regimen remains
             unchanged during the trial

          5. Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food
             poisoning, gastroenteritis, etc)

          6. Received any drug with potential anti-emetic effect within 24 hours prior to the start
             of qualifying LEC agent

          7. Scheduled to receive an antiemetic (with the exception of administration of the
             palonosetron) at any time during the trial, listed below

             -5-HT3 receptor antagonists

               -  NK1 receptor antagonists

               -  Dopamine receptor antagonists (metoclopramide)

               -  Phenothiazine anti-emetics (prochlorperazine, promethazine, thiethylperazine and
                  perphenazine)

               -  Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide.
                  Diphenhydramine will be allowed if given for prophylactic treatment of
                  hypersensitivity reactions associated with the administration of taxanes (e.g.,
                  paclitaxel, docetaxel) and ixabepilone

               -  All benzodiazepines except Triazolam or Zolpidem used once at night time due to
                  sleep disturbances

               -  Atypical antipsychotic agents with compazine-like activity (e.g., olanzapine,
                  risperidone)

               -  Butyrophenones (haloperidol, droperidol)

               -  Cannabinoides (tetrahydrocannabinol or nabilone)

               -  Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone),
                  with the exception of topical or inhaled preparations. Dexamethasone will be
                  allowed if given for prophylactic treatment of hypersensitivity reactions
                  associated with the administration of taxanes (e.g., paclitaxel, docetaxel) or
                  prevention of rash associated with pemetrexed. Prednisone will be allowed if
                  given for as part of standard regimen with mitoxantrone or docetaxel for prostate
                  cancer.

               -  Any non-prescription medication, nutritional supplements, vitamins or herbal-type
                  products known to either possibly cause nausea or vomiting, or used to treat
                  nausea or vomiting

          8. Having received any investigational drugs or devices within 30 days before study entry

          9. Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for
             Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding
             chemotherapy

         10. History of alcohol or drug abuse

         11. Scheduled to receive any other emetogenic chemotherapeutic agents during the study
             other than those specified in this protocol

         12. Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug
             excipients

         13. Scheduled to receive or have received radiotherapy within 1 week prior to or during
             the study

         14. Any condition that, in the judgment of the Principal Investigator, would make a
             subject ineligible for participation in the study