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

Chemotherapy-induced Nausea and Vomiting (CINV) Clinical Trial

Official title:

A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952341
• Other study ID #: 0869-169
• Secondary ID: 2009_626
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2009
• Last updated: May 2, 2017
• Start date: August 25, 2009
• Est. completion date: May 5, 2010

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: May 5, 2010
• Est. primary completion date: April 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• aprepitant
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
• Comparator: Placebo to aprepitant
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
• dexamethasone
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
• granisetron
Day 1: IV granisetron 3 mg prior to administration of cisplatin
• dexamethasone
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting follow — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.	0 to 120 hours
Secondary	Proportion of Participants With Complete Response in the Acute Phase of Cycle 1	Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.	0 to 24 hours
Secondary	Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1	Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.; Complete response was defined as no vomiting with no rescue therapy.	25 to 120 hours
Secondary	Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1	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).	0 to 120 hours
Secondary	Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1	Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.	0 to 24 hours
Secondary	Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1	Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy	25 to 120 hours
Secondary	Proportion of Participants With No Impact on Daily Life in Cycle 1	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).	0 to 120 hours
Secondary	Time to First Vomiting Episode in Cycle 1	Time from administration of chemotherapy to first vomiting episode.	0 to 120 hours