Trial Outcomes & Findings for Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin (NCT NCT01012336)

Results Overview

Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

120 hours

Results posted on

2012-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Aprepitant Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
Overall Study STARTED	85
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant n=85 Participants Aprepitant is a selective, high-affinity NK1 receptor antagonist
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age Continuous	54.9 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	85 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 hours

Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).

Outcome measures

Outcome measures
Measure	Aprepitant n=85 Participants Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.	89.4 Percentage of Participants

PRIMARY outcome

Timeframe: 120 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 hours

Outcome measures

Outcome data not reported

Adverse Events

Aprepitant

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aprepitant n=89 participants at risk Aprepitant is a selective, high-affinity NK1 receptor antagonist
Blood and lymphatic system disorders Neutropenic fever	2.2% 2/89 • Number of events 2

Other adverse events

Other adverse events
Measure	Aprepitant n=89 participants at risk Aprepitant is a selective, high-affinity NK1 receptor antagonist
Gastrointestinal disorders constipation	15.7% 14/89 • Number of events 14
General disorders fatigue	14.6% 13/89 • Number of events 13
Nervous system disorders headache	13.5% 12/89 • Number of events 12

Additional Information

Pf Duk-Soo Bae

Samsung Medical Center

Phone: 82-2-3410-3519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place