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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00952341
First received: July 31, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 25 to 120 hours ] [ Designated as safety issue: No ]

    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 Overall Phase of Cycle 1 [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
    Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.

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

  • Proportion of Participants With No Impact on Daily Life in Cycle 1 [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]
    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).

  • Time to First Vomiting Episode in Cycle 1 [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]
    Time from administration of chemotherapy to first vomiting episode.


Enrollment: 421
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952341

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00952341     History of Changes
Other Study ID Numbers: 0869-169, 2009_626
Study First Received: July 31, 2009
Results First Received: July 1, 2011
Last Updated: April 9, 2014
Health Authority: China: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
CINV

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Dexamethasone
Dexamethasone acetate
Aprepitant
Fosaprepitant
Granisetron
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014