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Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vomiting

Intervention: aprepitant (Drug); ondansetron (Drug); dexamethasone (Drug); placebo to aprepitant (Drug); placebo to dexamethasone (Drug); rescue medication (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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 emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)

Secondary outcome:

Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1)

Percentage of Participants Who Experience Absence of Nausea (Cycle 1)

Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)

Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10)

Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)

Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)

Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)

Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)

Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics

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 cycles.

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course

of chemotherapy.

Locations and Contacts

Additional Information

Related publications:

Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7. doi: 10.1002/pbc.21811.

Starting date: April 2004
Last updated: August 4, 2014

Page last updated: August 23, 2015

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