An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

Breast Neoplasms Clinical Trial

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 Associated With Moderately Emetogenic Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092183
• Other study ID #: 0869-071
• Secondary ID: MK0869-0712004_0
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2004
• Last updated: May 2, 2017
• Start date: October 10, 2002
• Est. completion date: February 11, 2004

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 866
• Est. completion date: February 11, 2004
• Est. primary completion date: December 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion Criteria:

• Patient has a central nervous system malignancy.

• Patient will receive radiation to the abdomen or pelvis.

Related Conditions & MeSH terms

• Breast Neoplasms
• Nausea
• Vomiting

Intervention

Drug:
• MK0869, aprepitant / Duration of Treatment: 3 days

• Comparator: ondansetron / Duration of Treatment: 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. Erratum in: J Clin Oncol. 2005 Aug 20;23(24):5851. Dosage error in published abstract; MEDLINE/PubMed abstract corrected. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emesis and use of rescue medication
Primary	Safety and tolerability
Secondary	Quality of life