Trial Outcomes & Findings for Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy (NCT NCT01031953)

Results Overview

The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline to 2 hours after study drug administered.

Results posted on

2017-05-09

Participant Flow

Participants were recruited from August 2008 until January 2013

There were 34 participants who signed the informed consent for this study but of these, only 11 received the study treatment. The other 23 were screen failures.

Participant milestones

Participant milestones
Measure	Fosaprepitant A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosaprepitant n=11 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 hours after study drug administered.

The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale	10 participants

SECONDARY outcome

Timeframe: Baseline to 12 hours after study drug administered.

The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Improvement in Nausea Score From Baseline to 12 Hours	11 participants

SECONDARY outcome

Timeframe: 2 hours to 24 hours after study drug administered.

The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Improvement in Nausea Score From 2 Hours to 24 Hours	7 participants

SECONDARY outcome

Timeframe: Baseline to 24 hours after study drug administered.

Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours	2 participants

SECONDARY outcome

Timeframe: 2 hours after administration of Fosaprepitant 150 mg IV

Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)	9 participants

SECONDARY outcome

Timeframe: up to 24 hours after receiving fosaprepitant

The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)	1 participants

SECONDARY outcome

Timeframe: up to 24 hours after study drug administered.

Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant	7 participants

SECONDARY outcome

Timeframe: up to 24 hours after study drug administered.

Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.

Outcome measures

Outcome measures
Measure	Participants Receiving Fosaprepitant n=11 Participants A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness	5 participants

Adverse Events

Fosaprepitant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fosaprepitant n=11 participants at risk
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 1
Nervous system disorders Confusion-ifosfamide encephalopathy	9.1% 1/11 • Number of events 1
General disorders Fatigue	9.1% 1/11 • Number of events 1
Respiratory, thoracic and mediastinal disorders hiccups	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Indigestion	9.1% 1/11 • Number of events 1
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1
Cardiac disorders Tachycardia	18.2% 2/11 • Number of events 2

Additional Information

Dr. Joseph Bubalo

Oregon Health & Science University

Phone: 503-494-8007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place