Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

Chemotherapy-Induced Nausea and Vomiting (CINV) Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594749
• Other study ID #: 0517-031
• Status: Completed
• Phase: Phase 3
• Start date: September 24, 2012
• Est. completion date: November 3, 2014

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1015
• Est. completion date: November 3, 2014
• Est. primary completion date: November 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a histologically or cytologically confirmed malignant disease

• Is naive to moderately and highly emetogenic chemotherapy

• Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide

• Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the participant requires occasional assistance, but is able to care for most of his/her needs.

• Female of childbearing potential demonstrates a negative urine pregnancy test, and agrees to remain abstinent or use two acceptable forms of birth control for at least 14 days prior to study, throughout the study, and at least 1 month following last dose of study drug.

Exclusion Criteria:

• Has vomited in the 24 hours prior to treatment Day 1

• Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting

• Is scheduled to receive chemotherapy agent classified as highly emetogenic

• Has received or will receive total body irradiation, or radiation therapy to the abdomen, pelvis, head and neck in the week prior to Treatment Days 1 through Day 6 of the Treatment Period

• Has illness or history of illness which might confound study results or pose unwarranted risk

• Known history of QT interval prolongation

• Uses illicit drugs or abuses alcohol

• Mentally incapacitated or has a significant emotional or psychiatric disorder

• History of hypersensitivity to aprepitant, ondansetron or dexamethasone

• Pregnant or breast-feeding

• Has participated in a study with aprepitant or taken a non-approved (investigational) drug within the last 4 weeks

• Has concurrent condition, such as systemic fungal infection or uncontrolled diabetes, that precludes administration of dexamethasone.

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting (CINV)
• Nausea
• Vomiting

Intervention

Drug:
• Fosaprepitant dimeglumine

• Fosaprepitant Placebo

• Dexamethasone

• Ondansetron

• Dexamethasone Placebo

• Ondansetron Placebo

• Rescue Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)	A Complete Response was defined as no vomiting and no use of rescue medication.	25 to 120 hours after initiation of MEC
Primary	Percentage of Participants With Infusion-site Thrombophlebitis	The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.	Day 1 through Day 17, inclusive
Primary	Percentage of Participants With Severe Infusion-site Reactions	The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.	Day 1 through Day 17, inclusive
Secondary	Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC	A Complete Response was defined as no vomiting and no use of rescue medication.	0 to 120 hours after initiation of MEC
Secondary	Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC	A Complete Response was defined as no vomiting and no use of rescue medication.	0 to 24 hours after initiation of MEC
Secondary	Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC	No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.	0 to 120 hours after initiation of MEC