Trial Outcomes & Findings for Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer (NCT NCT00903396)

NCT ID: NCT00903396

Last Updated: 2017-11-24

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2017-11-24

Participant Flow

Participant milestones

Participant milestones
Measure
Arm I
Patients receive palonosetron hydrochloride IV on day 1. palonosetron hydrochloride: Given IV
Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4. palonosetron hydrochloride: Given IV
Arm III
Patients receive placebo IV on day 1. placebo: Given IV
Arm IV
Patients receive placebo IV on days 1 and 4. placebo: Given IV
Overall Study
STARTED
2
1
3
1
Overall Study
COMPLETED
2
1
3
1
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm II

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm III

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm IV

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michele Halyard, M.D.

Mayo Clinic

Phone: 4803014567

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place