Trial · NCT01031953

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

NCT01031953, Phase 1, Phase 2, Terminated, OHSU Knight Cancer Institute; results first posted 2014-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy. Trials, record NCT01031953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01031953

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
NCT number: NCT01031953
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 34 participants, actual
Lead sponsor: OHSU Knight Cancer Institute
Conditions: Breakthrough Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Interventions: fosaprepitant dimeglumine, systemic chemotherapy, survey administration, quality-of-life assessment
First posted: 2009-12-15
Last updated: 2017-05-09
Results first posted: 2014-01-30
Limitations and caveats: * Missing data did affect results for the 24 hour mark~* Lack of control group to measure possible neurokinin-1 antagonist (NK1a) inhibition

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale	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.
Secondary	Improvement in Nausea Score From Baseline to 12 Hours	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.
Secondary	Improvement in Nausea Score From 2 Hours to 24 Hours	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.
Secondary	Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours	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.
Secondary	Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)	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
Secondary	Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)	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
Secondary	Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant	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).
Secondary	Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale	Baseline to 2 hours after study drug administered.	participants	NUMBER
SECONDARY	Improvement in Nausea Score From Baseline to 12 Hours	Baseline to 12 hours after study drug administered.	participants	NUMBER
SECONDARY	Improvement in Nausea Score From 2 Hours to 24 Hours	2 hours to 24 hours after study drug administered.	participants	NUMBER
SECONDARY	Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours	Baseline to 24 hours after study drug administered.	participants	NUMBER
SECONDARY	Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)	2 hours after administration of Fosaprepitant 150 mg IV	participants	NUMBER
SECONDARY	Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)	up to 24 hours after receiving fosaprepitant	participants	NUMBER
SECONDARY	Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant	up to 24 hours after study drug administered.	participants	NUMBER
SECONDARY	Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness	up to 24 hours after study drug administered.	participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale	Participants Receiving Fosaprepitant	10	participants
Improvement in Nausea Score From Baseline to 12 Hours	Participants Receiving Fosaprepitant	11	participants
Improvement in Nausea Score From 2 Hours to 24 Hours	Change in Nausea Score From 2 Hours to 12 and 24 Hours	7	participants
Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours	Participants Who Recieved Fosaprepitant	2	participants
Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)	Participants That Received Fosaprepitant	9	participants
Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)	Participants That Received Fosaprepitant	1	participants
Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant	Participants That Received Fosaprepitant	7	participants
Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness	Participants That Received Fosaprepitant	5	participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fosaprepitant	11
Overall Study	COMPLETED	Fosaprepitant	11
Overall Study	NOT COMPLETED	Fosaprepitant	0

Source ClinicalTrials.gov

Adverse events7

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Fosaprepitant	1	11	1
other	Confusion-ifosfamide encephalopathy	Nervous system disorders	Fosaprepitant	1	11	1
other	Fatigue	General disorders	Fosaprepitant	1	11	1
other	hiccups	Respiratory, thoracic and mediastinal disorders	Fosaprepitant	1	11	1
other	Indigestion	Gastrointestinal disorders	Fosaprepitant	1	11	1
other	Insomnia	Psychiatric disorders	Fosaprepitant	1	11	1
other	Tachycardia	Cardiac disorders	Fosaprepitant	2	11	2

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fosaprepitant
Total, other adverse events	Fosaprepitant	7	11
Total, serious adverse events	Fosaprepitant	0	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA069533	OHSU Knight Cancer Institute	KUMMAR, SHIVAANI	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1997 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01031953

GET https://conductscience.org/api/trials/v1/NCT01031953/registered

API reference For AI assistants