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

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Cisplatin Granisetron hydrochloride Granisetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00952341 History of Changes
Other Study ID Numbers:	MK-0869-169, 2009_626
Study First Received:	July 31, 2009
Results First Received:	July 1, 2011
Last Updated:	August 23, 2011
Health Authority:	China: Ministry of Health

Keywords provided by Merck:

CINV

Additional relevant MeSH terms:

Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Dexamethasone
Dexamethasone acetate
Granisetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
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
Serotonin Antagonists

ClinicalTrials.gov processed this record on May 19, 2013