- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952341
Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aprepitant (MK-0869)
|
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
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
|
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
0 to 120 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
0 to 24 hours
|
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. |
25 to 120 hours
|
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). |
0 to 120 hours
|
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.
|
0 to 24 hours
|
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
|
25 to 120 hours
|
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).
|
0 to 120 hours
|
Time to First Vomiting Episode in Cycle 1
Time Frame: 0 to 120 hours
|
Time from administration of chemotherapy to first vomiting episode.
|
0 to 120 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Serotonin Agents
- Serotonin Antagonists
- Neurokinin-1 Receptor Antagonists
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Granisetron
- Aprepitant
- Fosaprepitant
Other Study ID Numbers
- 0869-169
- 2009_626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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