Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337727
First received: June 14, 2006
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Drug: aprepitant
Drug: Comparator: ondansetron
Drug: Comparator: dexamethasone
Drug: Comparator: fosaprepitant dimeglumine
Drug: Comparator; Placebo (unspecified)
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: Prevention
Official Title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients Who Reported No Vomiting [ Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1. ] [ Designated as safety issue: No ]

    The number of patients who reported No Vomiting in the overall phase in Cycle

    1



Secondary Outcome Measures:
  • Number of Patients Who Reported Complete Response [ Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1 ] [ Designated as safety issue: No ]
    The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.


Enrollment: 848
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
Drug: aprepitant
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
Other Name: MK0869
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Name: Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Name: DEXAMETHASONE TABLETS USP
Drug: Comparator; Placebo (unspecified)
dexamethasone 12mg Pbo tablets.
2
Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Name: Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Name: DEXAMETHASONE TABLETS USP
Drug: Comparator: fosaprepitant dimeglumine
fosaprepitant dimeglumine 115 mg
Other Name: EMEND®
Drug: Comparator; Placebo (unspecified)
Aprepitant 80 mg & 125 mg Pbo capsules.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
  • Karnofsky score of 60 or greater

Exclusion Criteria:

  • Patient is scheduled to receive any dose of cisplatin
  • Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
  • Any allergies to study drug or antiemetics
  • Taking CYP3A4 substrates/prohibited medication
  • Significant medical or mental conditions
  • Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
  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: NCT00337727

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00337727     History of Changes
Other Study ID Numbers: 0869-130, 2006_016
Study First Received: June 14, 2006
Results First Received: September 30, 2009
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Fosaprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014