Trial Outcomes & Findings for Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients (NCT NCT00982995)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

96 hours after dosing

Results posted on

2015-12-04

Participant milestones
Measure	Palonosetron Palonosetron 0.25 mg I.V. bolus Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

Baseline characteristics by cohort
Measure	Palonosetron n=3 Participants Palonosetron 0.25 mg I.V. bolus Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
Age, Continuous	65 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants

Timeframe: 96 hours after dosing

Population: The study was unable to accrue the required number of patients to analyze the primary outcome.

Outcome data not reported

Timeframe: 96 hours after dosing

Population: The study was unable to accrue the required number of patients to analyze the primary outcome.

Outcome data not reported

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Palonosetron n=3 participants at risk Palonosetron 0.25 mg I.V. bolus Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.
Vascular disorders Thromboembolic Event	33.3% 1/3 • Number of events 1

University of Michgan Comprehensive Cancer Center

Phone: 734-615-4762