Phase 3 N=848 Randomized Double-blind Prevention

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

Chemotherapy-Induced Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT00337727 ↗

Enrolled (actual)

848

Serious AEs

3.8%

Results posted

Nov 2009

Primary outcome: Primary: Number of Patients Who Reported No Vomiting — 324; 252 Participants — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: aprepitant (Drug); Comparator: ondansetron (Drug); Comparator: dexamethasone (Drug); Comparator: fosaprepitant dimeglumine (Drug); Comparator; Placebo (unspecified) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Who Reported No Vomiting	324; 252	<0.01 sig
SECONDARY Number of Patients Who Reported Complete Response	292; 229	<0.01 sig

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.

Eligibility 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).

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Data sourced from ClinicalTrials.gov (NCT00337727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.