Status:
COMPLETED
Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Vomiting
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emeto...
Detailed Description
The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day...
Eligibility Criteria
Inclusion
- Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
- Cycle 1: Participant has Karnofsky score ≥60
- Cycle 1: Participant has a predicted life expectancy of ≥3 months
Exclusion
- Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00080444
Start Date
April 1 2004
End Date
March 1 2007
Last Update
August 5 2014
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