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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.
Full description
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.
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Inclusion and exclusion criteria
Inclusion Criteria
In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator
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.
Previous use of palonosetron in association with a LEC regimen
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
Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc)
Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent
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
Having received any investigational drugs or devices within 30 days before study entry
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
History of alcohol or drug abuse
Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in this protocol
Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients
Scheduled to receive or have received radiotherapy within 1 week prior to or during the study
Any condition that, in the judgment of the Principal Investigator, would make a subject ineligible for participation in the study
Primary purpose
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Interventional model
Masking
36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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