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

NCT ID: NCT00952341

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-25
• Study Completion Date: 2010-05-05

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.

Conditions

Chemotherapy-induced Nausea and Vomiting (CINV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aprepitant (MK-0869)

Group Type: EXPERIMENTAL

aprepitant

Intervention Type: DRUG

Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg

granisetron

Intervention Type: DRUG

Day 1: IV granisetron 3 mg prior to administration of cisplatin

dexamethasone

Intervention Type: DRUG

Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Standard Therapy

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo to aprepitant

Intervention Type: DRUG

Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg

dexamethasone

Intervention Type: DRUG

Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg

granisetron

Intervention Type: DRUG

Day 1: IV granisetron 3 mg prior to administration of cisplatin

Interventions

aprepitant

Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg

Intervention Type: DRUG

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

Intervention Type: DRUG

dexamethasone

Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg

Intervention Type: DRUG

granisetron

Day 1: IV granisetron 3 mg prior to administration of cisplatin

Intervention Type: DRUG

dexamethasone

Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

Reference Type: RESULT

PMID: 24276953 (View on PubMed)

Other Identifiers

2009_626

Identifier Type: -

Identifier Source: secondary_id

0869-169

Identifier Type: -

Identifier Source: org_study_id