Efficacy of Aprepitant (Emend®) in Children

Completed · Phase 3 · Has a placebo group

Conditions studied: Nausea, Vomiting, Childhood Cancer

In brief

The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.

Key facts

Study ID

NCT01661335

Run by

University of Oklahoma

People needed

19

Starts

2012-06-01

Expected to finish

2017-06-29

Last updated by the study team

2021-03-23

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• under 20.99 years of age at enrollment
• Scheduled to receive two identical cycles of highly emetogenic[1] chemotherapy for treatment of a primary malignancy, including:
• Chemotherapy with any one or more of the following single agents in any combination:
• Carboplatin
• Carmustine >250 mg/m2
• Cisplatin
• Cyclophosphamide ≥1 g/m2
• Dactinomycin
• High dose Methotrexate ≥ 5 g/m2
• Or any of the following defined combinations:
• Cyclophosphamide + anthracycline
• Cyclophosphamide + etoposide
• Cytarabine 150-200 mg/m2 + daunorubicin
• Cytarabine 300 mg/m2 + etoposide
• Cytarabine 300 mg/m2 + teniposide
• Doxorubicin + ifosfamide
• Doxorubicin + methotrexate 5 g/m2
• Etoposide + ifosfamide

You may not qualify if…

• Patients who have received aprepitant in the past.
• Patients who demonstrate evidence of increased intracranial pressure.

Where it is running

• Jimmy Everest Center for Cancer and Blood Disorders in Children — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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