MedDataX Logo

Trial Outcomes & Findings for Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV (NCT NCT03008213)

NCT ID: NCT03008213

Last Updated: 2019-12-09

Results Overview

The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days. For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Through study completion, 7 days

Results posted on

2019-12-09

Participant Flow

Participant milestones

Participant milestones
Measure
Netupitant and Palonosetron
Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Netupitant and Palonosetron
n=1 Participants
Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, 7 days

The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days. For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.

Outcome measures

Outcome measures
Measure
Netupitant and Palonosetron
n=1 Participants
Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron
Number of Participants Completed All Study Procedures Over Seven Days
1 participants

Adverse Events

Netupitant and Palonosetron

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Netupitant and Palonosetron
n=1 participants at risk
Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Netupitant and Palonosetron: 300 mg of netupitant and 0.5 mg of palonosetron
Gastrointestinal disorders
nausea
100.0%
1/1 • Number of events 1 • 1 month

Additional Information

Eric Roeland, MD

UCSD

Phone: 858- 534-7079

Results disclosure agreements

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