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)
Completed · Phase 2
Conditions studied: Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
In brief
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.
Key facts
- Study ID
- NCT01054456
- Run by
- Eisai Inc.
- People needed
- 36
- Starts
- 2009-10-27
- Expected to finish
- 2010-12-08
- Last updated by the study team
- 2020-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
- Provide written informed consent
- Male or female ≥18 years of age
- Histologically or cytologically confirmed malignant disease
- Karnofsky Index of 50%
- Experienced either vomiting and/or at least moderate nausea during their last cycle of LEC
- Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC agents listed in the protocol.
- 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:
- 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
- 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)
Where it is running
- Sheridan Clinical Research — Sunrise, Florida, United States
- Medical and Surgical Specialists — Galesburg, Illinois, United States
- Orchard Healthcare Research Inc — Skokie, Illinois, United States
- Trover Center for Clinical Studies; Merle Mahr Cancer Center — Madisonville, Kentucky, United States
- Hematology- Oncology Associates of Rockland, PC — Nyack, New York, United States
- Signal Point Clinical Research — Middletown, Ohio, United States
- Scott and White Clinic- College Station — College Station, Texas, United States
- Scott and White Healthcare- Round Rock — Round Rock, Texas, United States
- Scott and White Memorial Hospital — Temple, Texas, United States
Full record on ClinicalTrials.gov
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