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

Chemotherapy-Induced Nausea and Vomiting 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 (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337727
• Other study ID #: 0869-130
• Secondary ID: 2006_016
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2006
• Last updated: June 8, 2015
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• aprepitant
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
• Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
• Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
• Comparator: fosaprepitant dimeglumine
fosaprepitant dimeglumine 115 mg
• Comparator; Placebo (unspecified)
dexamethasone 12mg Pbo tablets.
• Comparator; Placebo (unspecified)
Aprepitant 80 mg & 125 mg Pbo capsules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Reported No Vomiting	The number of patients who reported No Vomiting in the overall phase in Cycle; 1	Overall phase (0-120 hours post initiation of MEC) in Cycle 1.	No
Secondary	Number of Patients Who Reported Complete Response	The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.	Overall phase (0-120 hours post initiation of MEC) in Cycle 1	No

External Links

•   (MedWatch - FDA maintained medical product safety Information)
•   (Merck: Patient & Caregiver U.S. Product Web Site)