Evaluation of Fosaprepitant (MK0517) in Single Dose Sched... | NCT00619359

Evaluation of Fosaprepitant (MK0517) in Single Dose Sched... | NCT00619359 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Arm 1: study medication	Drug: Comparator: fosaprepitant dimeglumine Drug: Dexamethasone Drug: Ondansetron
2	Active Comparator	Arm 2: Active comparator	Drug: Comparator: Aprepitant Drug: Dexamethasone Drug: Ondansetron

Name	Type	Description	Arm Group Labels	Other Names
Comparator: fosaprepitant dimeglumine	Drug	single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).	The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.	Overall (in the 120 hours following initiation of cisplatin chemotherapy).

Secondary Outcomes

Measure	Description	Time Frame
A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).	The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.	Delayed phase (25 to 120 hours following initiation of cisplatin).

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21383291	Result	Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.

Arm/Group Information

ID	Title	Description
FG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
FG001	Aprepitant	Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001147 subjects FG0011175 subjects
COMPLETED		FG0001080 subjects FG0011094 subjects
NOT COMPLETED		FG00067 subjects FG00181 subjects

Type	Comment	Reasons
Adverse Event		FG00032 subjects FG00136 subjects
Lost to Follow-up		FG00012 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
BG001	Aprepitant

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.

Posted

Number

Participants

Overall (in the 120 hours following initiation of cisplatin chemotherapy).

ID	Title	Description
OG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. 4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 12.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 12.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp	1-800-672-6372

Condition Browse Module

ID	Term
D014839	Vomiting

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D003907	Dexamethasone
D017294	Ondansetron

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG00032 BG00133 BG00265

Asian

Title	Measurements
	BG000296 BG001306 BG002602

Black or African American

Title	Measurements
	BG00021 BG00122 BG00243

Multi-Racial

Title	Measurements
	BG000149 BG001157 BG002306

Native Hawaiian or Pacific Islander

Title	Measurements
	BG0001 BG0012 BG0023

White

Title	Measurements
	BG000648 BG001655 BG0021303

History of Motion Sickness

Includes treated patients only.

Number

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0000 BG0013 BG0023

Title	Measurements
	BG0001143 BG0011166 BG0022309

No Data - Assessment Not Completed

Title	Measurements
	BG0004 BG0016 BG00210

History of Vomiting with Pregnancy

Measure is specific to female treated patients only.

Number

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0003 BG0013 BG0026

Title	Measurements
	BG000420 BG001421 BG002841

Female Patients with No Data - No Assessment

Title	Measurements
	BG0002 BG0013 BG0025

Not Applicable - Male Patients

Title	Measurements
	BG000722 BG001748 BG0021470

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	-0.4	Standard Error of the Mean	3.7		95	-4.1	3.3					Non-Inferiority or Equivalence	If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.

Secondary

A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.

Posted

Number

Participants

Delayed phase (25 to 120 hours following initiation of cisplatin).

ID	Title	Description
OG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
OG001	Aprepitant	Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.

Units	Counts
Participants	OG0001106 OG0011133

Title

Denominators

Categories

Title	Measurements
	OG000822 OG001841

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	0.1	Standard Error of the Mean	3.6		95	-3.5	3.7					Non-Inferiority or Equivalence	If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.

Secondary

No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)

The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.

Posted

Number

Participants

Overall (the 120 hours following initiation of cisplatin chemotherapy)

ID	Title	Description
OG000	Fosaprepitant	Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
OG001	Aprepitant	Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.

Units	Counts
Participants	OG0001106 OG0011132

Title

Denominators

Categories

Title	Measurements
	OG000806 OG001844

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	-1.7	Standard Error of the Mean	3.6		95	-5.3	2.0					Non-Inferiority or Equivalence	If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.

ID	Type	Description	Link
MK0517-017
2007_594