Status:
COMPLETED
Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-induced Nausea and Vomiting (CINV)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2010
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00952341
Start Date
August 25 2009
End Date
May 5 2010
Last Update
June 2 2017
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