Fosaprepitant (EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030 AM1) (EVADE)

This study is currently recruiting participants.

Verified March 2013 by Merck

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01405924

First received: July 28, 2011

Last updated: March 22, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 28, 2011

Last Updated Date

March 22, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall proportion of participants with no vomiting or retching [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01405924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of participants with no vomiting or retching per type of chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fosaprepitant (EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030 AM1)

Official Title ^ICMJE

EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

Brief Summary

This study will assess the efficacy of a single dose of fosaprepitant as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Drug: fosaprepitant dimeglumine
150 mg intravenously (IV) on Day 1 of chemotherapy

Other Name: MK-0517, EMEND® IV
Drug: 5HT3 RA
5HT3 RA will be administered at the same dosage used in the first cycle of chemotherapy
Drug: dexamethasone
dexamethasone will be administered at the same dosage used in the first cycle of chemotherapy

Study Arm (s)

Experimental: Breast Cancers
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy
Interventions:
- Drug: fosaprepitant dimeglumine
- Drug: 5HT3 RA
- Drug: dexamethasone
Experimental: Gynecological Cancers
Women with breast cancer receiving carboplatin-paclitaxel chemotherapy
Interventions:
- Drug: fosaprepitant dimeglumine
- Drug: 5HT3 RA
- Drug: dexamethasone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with either breast or gynecological cancer
Receiving either AC-like or carboplatin-paclitaxel MEC
Experienced at least 1 episode of vomiting or retching during the first 5 days following cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant
No change in chemotherapy at cycle 2
No change in cycle 1 antiemetic regimen at cycle 2
Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

Requires increase in systemic corticosteroid therapy
Used benzodiazepines or opiates in the 48 hours prior to cycle 2 chemotherapy
Received or will receive radiation therapy to the abdomen or pelvis in the week prior to visit 1 or in days 1-6 following chemotherapy
Vomited in the 24 hours prior to Treatment Day 1
Pregnant or breast-feeding
Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks
Symptomatic central nervous system metastasis
History of other malignancies in the last 2 years

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01405924

Other Study ID Numbers ^ICMJE

0517-030

Has Data Monitoring Committee

Responsible Party

Merck

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Merck

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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