Phase 3
Completed N=848
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
Source: ClinicalTrials.gov NCT00337727 ↗Enrolled (actual)
848
Serious AEs
3.8%
Results posted
Nov 2009
Primary outcomePrimary: Number of Patients Who Reported No Vomiting — 324; 252 Participants — p=<0.01
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.
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 |
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).
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. Informational only — not medical advice.