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

NCT00952341 | Completed Phase 3 Results

• 2 other identifiers: 0869-1692009_626
• Study Type: interventional
• Target: 421
• Locations: 0 countries
• Sites: N/A

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)

Keywords

CINV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Participants With Complete Response in the Acute Phase of Cycle 1

  0 to 24 hours

• Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1

  25 to 120 hours

• Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1

  0 to 120 hours

• Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1

  0 to 24 hours

• Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1

  25 to 120 hours

Study Arms (2)

Aprepitant (MK-0869)

EXPERIMENTAL

Drug: aprepitant; Drug: granisetron; Drug: dexamethasone

Standard Therapy

PLACEBO COMPARATOR

Drug: Comparator: Placebo to aprepitant; Drug: dexamethasone; Drug: granisetron

Interventions

aprepitant DRUG

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

Aprepitant (MK-0869)

Comparator: Placebo to aprepitant DRUG

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

Standard Therapy

dexamethasone DRUG

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

Standard Therapy

granisetron DRUG

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

Aprepitant (MK-0869); Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 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.

  PMID: 24276953 RESULT

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant; Dexamethasone; Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 6, 2009
• Study Start: August 25, 2009
• Primary Completion: April 4, 2010
• Study Completion: May 5, 2010
• Last Updated: June 2, 2017
• Results First Posted: September 27, 2011

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share