Trial Outcomes & Findings for Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting (NCT NCT00412425)

Results Overview

Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

7 days

Results posted on

2012-05-04

Participant Flow

Recruitment period: 11/17/2006 - 8/1/2008. All recruitment done at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	3 Days Palonosetron 3 Days Palonosetron 0.25 mg intravenous (IV)	2 Days Palonosetron 2 Days Palonosetron 0.25 mg IV
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3 Days Palonosetron n=15 Participants 3 Days Palonosetron 0.25 mg intravenous (IV)	2 Days Palonosetron n=15 Participants 2 Days Palonosetron 0.25 mg IV	Total n=30 Participants Total of all reporting groups
Age Continuous	55 years n=5 Participants	49 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Analysis was per protocol.

Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

Outcome measures

Outcome measures
Measure	3 Days Palonosetron n=15 Participants 3 Days Palonosetron 0.25 mg intravenous (IV)	2 Days Palonosetron n=15 Participants 2 Days Palonosetron 0.25 mg IV
Cumulative Participants Response to Palonosetron Nausea Episodes (First 7 days)	85 episodes of nausea/vomiting	139 episodes of nausea/vomiting
Cumulative Participants Response to Palonosetron Vomiting Episodes (First 7 days)	44 episodes of nausea/vomiting	72 episodes of nausea/vomiting

Adverse Events

3 Days Palonosetron

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

2 Days Palonosetron

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	3 Days Palonosetron n=15 participants at risk 3 Days Palonosetron 0.25 mg intravenous (IV)	2 Days Palonosetron n=15 participants at risk 2 Days Palonosetron 0.25 mg IV
Gastrointestinal disorders Nausea	100.0% 15/15 • Number of events 128 • 19 months	93.3% 14/15 • Number of events 207 • 19 months
Gastrointestinal disorders Vomiting	73.3% 11/15 • Number of events 57 • 19 months	86.7% 13/15 • Number of events 89 • 19 months

Additional Information

Agop Bedikian, MD Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place