VomitingPhase 3NCT00080444

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

A Phase 3 study testing aprepitant, ondansetron and dexamethasone in people with Vomiting, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Vomiting
What is being tested?: aprepitant, ondansetron and dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: No sites listed yet
Study dates: Apr 2004to Mar 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions: Vomiting
Being tested: aprepitant, ondansetron, dexamethasone, placebo to aprepitant, placebo to dexamethasone
Medical subject headings: Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aprepitantDrug
aprepitant capsules
ondansetronDrug
ondansetron IV preparation
dexamethasoneDrug
dexamethasone tablets
placebo to aprepitantDrug
Matching placebo to aprepitant capsules
placebo to dexamethasoneDrug
Matching placebo to dexamethasone tablets
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.

Study groups in NCT00080444
Study group	Role	What they receive
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. Receives: Drug: aprepitant; Drug: ondansetron; Drug: dexamethasone; Drug: placebo to dexamethasone; Drug: 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. Receives: Drug: ondansetron; Drug: dexamethasone; Drug: placebo to aprepitant; Drug: 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. Receives: Drug: aprepitant; Drug: ondansetron; Drug: dexamethasone; Drug: placebo to dexamethasone; Drug: rescue medication

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)
Measured: 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)
Measured: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Absence of Nausea (Cycle 1)
Measured: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)
Measured: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)
Measured: 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)
Measured: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)
Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)
Measured: Up to Day 4 of Cycles 2-10 (Up to 10 months)
Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)
Measured: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)
Measured: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)
Measured: Up to Day 4 of Cycle 1
Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics
Measured: Up to 24 hours after first dose of aprepitant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2004Mar 2007

First posted2 Apr 2004 (estimated)
Study startApr 2004
Primary completionSep 2006
Study completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VomitingStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00080444
Sponsor's protocol ID: 0869-097
Other IDs: Formerly-0304AHEC, MK-0869-097, 2004_099
Status last verified: Aug 2014
First submitted: 31 Mar 2004
Last updated: 5 Aug 2014
Results posted: No
Data monitoring committee: No

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.
PubMed 18985740

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
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BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
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All Vomiting trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00080444
Acronym / sponsor ID: 0869-097
Conditions: Vomiting
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Sep 2006 (actual)
Study completion: Mar 2007 (actual)
First posted: 2 Apr 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Part 1: Aprepitant	Experimental	Drug: aprepitant, Drug: ondansetron, Drug: dexamethasone, Drug: placebo to dexamethasone, Drug: rescue medicationDay 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.
Part 1: Standard Therapy	Active comparator	Drug: ondansetron, Drug: dexamethasone, Drug: placebo to aprepitant, Drug: rescue medicationDay 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.
Part 2: Aprepitant	Active comparator	Drug: aprepitant, Drug: ondansetron, Drug: dexamethasone, Drug: placebo to dexamethasone, Drug: rescue medicationDay 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.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aprepitantaprepitant capsules	Drug	Part 1: Aprepitant, Part 2: Aprepitant
ondansetronondansetron IV preparation	Drug	Part 1: Aprepitant, Part 1: Standard Therapy, Part 2: Aprepitant
dexamethasonedexamethasone tablets	Drug	Part 1: Aprepitant, Part 1: Standard Therapy, Part 2: Aprepitant
placebo to aprepitantMatching placebo to aprepitant capsules	Drug	Part 1: Standard Therapy
placebo to dexamethasoneMatching placebo to dexamethasone tablets	Drug	Part 1: Aprepitant, Part 2: Aprepitant
rescue medicationParticipants 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.	Drug	Part 1: Aprepitant, Part 1: Standard Therapy, Part 2: Aprepitant

Primary outcome

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1)
Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)

10 secondary outcomes

Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1)
Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Absence of Nausea (Cycle 1)
Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Absence of Vomiting (Cycle 1)
Time frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1
Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10)
Time frame: 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)
Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months)
Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10)
Time frame: Up to Day 4 of Cycles 2-10 (Up to 10 months)
Percentage of Participants Who Experience Serious Adverse Events (Cycle 1)
Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1)
Time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)
Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1)
Time frame: Up to Day 4 of Cycle 1
Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics
Time frame: Up to 24 hours after first dose of aprepitant

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Background: PubMed 18985740Gore 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.

Related trials for Vomiting

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aprepitant, ondansetron and dexamethasone in people with Vomiting, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1) (time frame: Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.