Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092196

Purpose

The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

Condition	Intervention	Phase
Nausea Vomiting Breast Neoplasms	Drug: MK0869, aprepitant / Duration of Treatment: 3 days	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nausea and Vomiting

Drug Information available for: Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Open-Label Extension to: 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 Associated With Moderately Emetogenic Chemotherapy

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability

Secondary Outcome Measures:

Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

Estimated Enrollment:	820
Study Start Date:	December 2002

Eligibility

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

Criteria

Inclusion Criteria:

Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
Patient must have completed participation in the main study for this protocol.

Exclusion Criteria:

Patient has a central nervous system malignancy.
Patient will receive radiation to the abdomen or pelvis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092196

Locations

United States, Pennsylvania
Call for Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Publications:

Herrstedt J, Muss HB, Warr DG, Hesketh PJ, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Hustad CM, Horgan KJ, Skobieranda F; Aprepitant Moderately Emetogenic Chemotherapy Study Group. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapy. Cancer. 2005 Oct 1;104(7):1548-55. Erratum in: Cancer. 2006 Apr 1;106(7):1641.

Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30.

Study ID Numbers:	2004_064
Study First Received:	September 21, 2004
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00092196
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Chemotherapy-Induced Nausea and Vomiting

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Skin Diseases

Breast Neoplasms
Nausea
Breast Diseases
Aprepitant

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs

Gastrointestinal Agents
Antiemetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009