Phase 3
Completed N=421
Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
Chemotherapy-induced Nausea and Vomiting (CINV)
Source: ClinicalTrials.gov NCT00952341 ↗
Enrolled (actual)
421
Serious AEs
1.7%
Results posted
Sep 2011
Primary outcomePrimary: Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 — 0.696; 0.570 Proportion of participants — p=0.007
Summary
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 |
0.696; 0.570 | 0.007 sig |
| SECONDARY Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 |
0.794; 0.793 | 0.942 |
| SECONDARY Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1 |
0.740; 0.594 | 0.001 sig |
| SECONDARY Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1 |
0.706; 0.570 | 0.003 sig |
| SECONDARY Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1 |
0.804; 0.798 | 0.882 |
| SECONDARY Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1 |
0.740; 0.594 | 0.001 sig |
| SECONDARY Proportion of Participants With No Impact on Daily Life in Cycle 1 |
0.705; 0.683 | — |
| SECONDARY Time to First Vomiting Episode in Cycle 1 |
77.0; 76.0 | — |
Eligibility Criteria
Inclusion Criteria
Cycle 1:
- Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
- Patient has a predicted life expectancy of at least 3 months
- Patient is not pregnant
Cycle 2 (optional):
- Participation in the study during the next cycle of chemotherapy is considered
appropriate by the investigator and will not pose unwarranted risk to the patient.
- Satisfactory completion of the preceding cycle of chemotherapy and related
study procedures.
- Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new
dose is still no less than 70 mg/m^2.
Exclusion Criteria
Cycles 1 & 2:
- Patient will receive stem cell therapy in conjunction with cisplatin
- Patient has an active infection or any uncontrolled disease (e.g. diabetes)
- Patient will receive multiple-day chemotherapy with cisplatin
- Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
- Patient has vomited within 24 hours prior to cisplatin infusion
- Patient received or will receive radiation therapy to the abdomen
Data sourced from ClinicalTrials.gov (NCT00952341). 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.