NCT00080444

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2004

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.4 years

First QC Date

March 31, 2004

Last Update Submit

August 4, 2014

Conditions

Vomiting

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (10)

  • 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

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

    Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1

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

    Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1

  • 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)

  • 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)

  • +5 more secondary outcomes

Study Arms (3)

Part 1: Aprepitant

EXPERIMENTAL

Day 1: aprepitant 125 mg orally (PO), ondansetron 0.15 mg/kg x 3 doses intravenously (IV), dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For 1 cycle and up to 9 subsequent optional cycles.

Drug: aprepitantDrug: ondansetronDrug: dexamethasoneDrug: placebo to dexamethasoneDrug: rescue medication

Part 1: Standard Therapy

ACTIVE COMPARATOR

Day 1: placebo to aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 16 mg PO. Day 2: placebo to aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 3: placebo for aprepitant 80 mg PO, dexamethasone 8 mg PO. Day 4: dexamethasone 8 mg PO. For 1 cycle; participants may receive open-label aprepitant for up to 9 subsequent optional cycles.

Drug: ondansetronDrug: dexamethasoneDrug: placebo to aprepitantDrug: rescue medication

Part 2: Aprepitant

ACTIVE COMPARATOR

Day 1: aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For up to 10 cycles.

Drug: aprepitantDrug: ondansetronDrug: dexamethasoneDrug: placebo to dexamethasoneDrug: rescue medication

Interventions

aprepitantDRUG

aprepitant capsules

Part 1: AprepitantPart 2: Aprepitant
ondansetronDRUG

ondansetron IV preparation

Part 1: AprepitantPart 1: Standard TherapyPart 2: Aprepitant
dexamethasoneDRUG

dexamethasone tablets

Part 1: AprepitantPart 1: Standard TherapyPart 2: Aprepitant
placebo to aprepitantDRUG

Matching placebo to aprepitant capsules

Part 1: Standard Therapy
placebo to dexamethasoneDRUG

Matching placebo to dexamethasone tablets

Part 1: AprepitantPart 2: Aprepitant
rescue medicationDRUG

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.

Part 1: AprepitantPart 1: Standard TherapyPart 2: Aprepitant

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 18985740BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

AprepitantOndansetronDexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzolesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2004

First Posted

April 2, 2004

Study Start

April 1, 2004

Primary Completion

September 1, 2006

Study Completion

March 1, 2007

Last Updated

August 5, 2014

Record last verified: 2014-08