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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00952341
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : September 27, 2011
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting (CINV) Drug: aprepitant Drug: Comparator: Placebo to aprepitant Drug: dexamethasone Drug: granisetron Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 421 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2009
Actual Primary Completion Date : April 4, 2010
Actual Study Completion Date : May 5, 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Aprepitant (MK-0869) Drug: aprepitant
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg

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

Drug: dexamethasone
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Placebo Comparator: Standard Therapy 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

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 [ Time Frame: 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 :
  1. Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 [ Time Frame: 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.


  2. Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1 [ Time Frame: 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.


  3. Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1 [ Time Frame: 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).


  4. Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1 [ Time Frame: 0 to 24 hours ]
    Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.

  5. Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1 [ Time Frame: 25 to 120 hours ]
    Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy

  6. Proportion of Participants With No Impact on Daily Life in Cycle 1 [ Time Frame: 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).

  7. Time to First Vomiting Episode in Cycle 1 [ Time Frame: 0 to 120 hours ]
    Time from administration of chemotherapy to first vomiting episode.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952341


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00952341    
Other Study ID Numbers: 0869-169
2009_626
First Posted: August 6, 2009    Key Record Dates
Results First Posted: September 27, 2011
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme Corp.:
CINV
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Dexamethasone acetate
Aprepitant
Fosaprepitant
Granisetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents