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

Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080444
• Other study ID #: 0869-097
• Secondary ID: Formerly-0304AHE
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2004
• Last updated: August 4, 2014
• Start date: April 2004
• Est. completion date: March 2007

Study information

• Verified date: August 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• aprepitant
aprepitant capsules
• ondansetron
ondansetron IV preparation
• dexamethasone
dexamethasone tablets
• placebo to aprepitant
Matching placebo to aprepitant capsules
• placebo to dexamethasone
Matching placebo to dexamethasone tablets
• rescue medication
Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)		Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)	Yes
Secondary	Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1)		Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1	No
Secondary	Percentage of Participants Who Experience Absence of Nausea (Cycle 1)		Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1	No
Secondary	Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)		Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1	No
Secondary	Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)		Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)	Yes
Secondary	Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10)		Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)	Yes
Secondary	Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)		Up to Day 4 of Cycles 2-10 (Up to 10 months)	Yes
Secondary	Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)		Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)	Yes
Secondary	Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)		Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)	Yes
Secondary	Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)		Up to Day 4 of Cycle 1	Yes
Secondary	Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics		Up to 24 hours after first dose of aprepitant	No