Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Phase 3

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)
• Interventions: Drug: aprepitant; Drug: granisetron; Drug: dexamethasone

• Registration Number: NCT00952341
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2009-08-25
• Primary Completion: 2010-04-04
• Study Completion: 2010-05-05
• Disposition First Submitted: 2011-04-01
• Disposition First Submitted QC: 2011-04-22
• Disposition First Posted: 2011-04-29
• Results First Submitted: 2011-07-01
• Results First Submitted QC: 2011-08-23
• Results First Posted: 2011-09-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

Cycle 1:

• Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
• Patient has a predicted life expectancy of at least 3 months
• Patient is not pregnant

Cycle 2 (optional):

• Participation in the study during the next cycle of chemotherapy is considered

appropriate by the investigator and will not pose unwarranted risk to the patient.

• Satisfactory completion of the preceding cycle of chemotherapy and related

study procedures.

• Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new

dose is still no less than 70 mg/m^2.

Exclusion Criteria

Cycles 1 & 2:

• Patient will receive stem cell therapy in conjunction with cisplatin
• Patient has an active infection or any uncontrolled disease (e.g. diabetes)
• Patient will receive multiple-day chemotherapy with cisplatin
• Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
• Patient has vomited within 24 hours prior to cisplatin infusion
• Patient received or will receive radiation therapy to the abdomen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant (MK-0869)	aprepitant	-
Aprepitant (MK-0869)	granisetron	-
Aprepitant (MK-0869)	dexamethasone	-
Standard Therapy	dexamethasone	-
Standard Therapy	granisetron	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1	0 to 120 hours	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.

Secondary Outcome Measures

Name	Time	Method
Time to First Vomiting Episode in Cycle 1	0 to 120 hours	Time from administration of chemotherapy to first vomiting episode.
Proportion of Participants With No Impact on Daily Life in Cycle 1	0 to 120 hours	The Functional Living Index-Emesis is a self-administered, validated emesis \& nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea \& vomiting (CINV) on daily life" was defined as an average item score of \>6 on the 7-point scale (i.e., \>108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 \& 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1	0 to 120 hours	Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.; No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1	0 to 24 hours	Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1	0 to 24 hours	Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1	25 to 120 hours	Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1	25 to 120 hours	Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy