A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in … (NCT01054456) | Clinical Trial Compass
CompletedPhase 2
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)
United States36 participantsStarted 2009-10-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion criteria
✕. 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
What they're measuring
1
Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1
Timeframe: From 0 to 24 hours after receiving treatment on Day 1
2
Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1
Timeframe: From 24 to 120 hours after receiving treatment on Day 1
3
Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Timeframe: From 0 to 120 hours after receiving treatment on Day 1