A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134 AM3)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00818259
First received: January 6, 2009
Last updated: May 16, 2013
Last verified: April 2013
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Purpose
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Nausea and Vomiting |
Drug: Experimental: aprepitant Drug: Experimental: fosaprepitant Drug: Comparator: ondansetron |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy |
Resource links provided by NLM:
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Ondansetron hydrochloride
Ondansetron
Aprepitant
Fosaprepitant
Fosaprepitant dimeglumine
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Plasma concentration and PK parameters of aprepitant [ Time Frame: Predose up to 3 days post dose ] [ Designated as safety issue: No ]
- Number of participants experiencing adverse events (AEs) [ Time Frame: Day 1 up to Day 17 ] [ Designated as safety issue: Yes ]
- Number of participants discontinued from study to to AEs [ Time Frame: Day 1 up to Day 3 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 82 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part I - fosaprepitant/aprepitant/ondansetron
Part I includes participants 12-17 years of age and has two treatment plans (fosaprepitant and aprepitant, and fosaprepitant only).
|
Drug: Experimental: aprepitant
Part 1A (Completed): aprepitant 80 mg, orally (po), on Days 2 and 3 prior to chemotherapy for participants from 12-17 years of age. Participants will also receive ondansetron as per local standard of care. Aprepitant dosages may be adjusted based pharmacokinetic data.
Other Names:
Drug: Experimental: fosaprepitant
Part IA (completed): Day 1, fosaprepitant, intravenous (IV) at a dose of 115 mg for participants from 12-17 years of age. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Experimental: fosaprepitant
Part IB: Day 1, fosaprepitant, IV at a dose of 150 mg for participants 12-17 years of age. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Comparator: ondansetron
Ondansetron will be administered intravenously per local standard of care.
Other Name: Zofran
|
|
Experimental: Part II - aprepitant/ondansetron
Part II includes participants from birth to less than 12 year of age. Part II has 2 dosing levels of aprepitant (Step A and Step B).
|
Drug: Experimental: aprepitant
Part II Step A (Completed): aprepitant, po, on Day 1 prior to chemotherapy at 47 mg/m^2 for participants 6 months to <12 years of age. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Experimental: aprepitant
Part II Step A: Day 1, aprepitant, po, at a dose of 2 mg/kg for Participants from 4 to 6 months of age, 1.0 mg/kg for 1-4 months, and 0.5 mg/kg for <1 month. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Experimental: aprepitant
Part II Step B (completed): Day 1, aprepitant, po at a dose of 74 mg/m^2 for participants from 2 to <12 years of age, and 1.3 mg/kg for 6 months to <2 years. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Experimental: aprepitant
Part II Step B: Day 1, aprepitant po, at a dose of 3 mg/kg for participants from participants from 4 to 6 months of age, 1.5 mg/kg for 1-4 months, and 0.75 mg/kg for <1 month.Participants will also receive ondansetron as per local standard of care
Other Names:
Drug: Comparator: ondansetron
Ondansetron will be administered intravenously per local standard of care.
Other Name: Zofran
|
|
Active Comparator: Part III - ondansetron with/without IV dexamethasone
Part III includes participants from birth to less than 12 years of age. Participants from Part III may continue to Parts IV and V.
|
Drug: Comparator: ondansetron
Ondansetron will be administered intravenously per local standard of care.
Other Name: Zofran
|
|
Experimental: Part IV - aprepitant/ondansetron with/without IV dexamethasone
Part IV includes participants from birth to 12 years of age
|
Drug: Experimental: aprepitant
Part IV: Day 1, aprepitant, po at a dose of 125 mg/kg for participants 12-17 years of age, 3 mg/kg for 4 months to < 12 years, 1.5 mg/kg for 1-4 months, and 0.75 mg/kg for <1 month; Part IV Days 2 and 3, aprepitant, po at a dose of 80 mg/kg for participants from 12-17 years of age, 2 mg/kg for 4 months to <12 years, 1.0 mg/kg for 1-4 months, and 0.5 mg/kg for <1 month. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Comparator: ondansetron
Ondansetron will be administered intravenously per local standard of care.
Other Name: Zofran
|
|
Experimental: Part V - fosaprepitant/ondansetron
Part V includes participants from 6 months to less than 12 years of age
|
Drug: Experimental: fosaprepitant
Part V: Day 1, fosaprepitant, IV at a dose of 3 mg/kg for participants 6 months to <12 years of age. Participants will also receive ondansetron as per local standard of care.
Other Names:
Drug: Comparator: ondansetron
Ondansetron will be administered intravenously per local standard of care.
Other Name: Zofran
|
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant is 0 (at least 37 weeks gestation) to 17 years of age
- Participant is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated
- Participant is expected to receive ondansetron
- Female participants who have begun menstruating must have a negative pregnancy test
- Participant weighs ≥3.0 kg if <6 months of age,≥6.0 kg if >6 months of age, and ≥7.5 kg if > 2 years of age
- Participant has a preexisting venous catheter
Exclusion Criteria:
- Participant uses any illicit drugs or abuses alcohol
- Participant is pregnant or breast feeding
- Participant has a symptomatic CNS tumor
- Participant has an infection or other uncontrolled disease other than cancer
- Known history of heart QT wave prolongation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818259
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Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
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| United States, Colorado | |
| Call for Information (Investigational Site 0001) | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Call for Information (Investigational Site 0041) | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Call for Information (Investigational Site 0042) | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Massachusetts | |
| Call for Information (Investigational Site 0020) | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Call for Information (Investigational Site 0043) | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, South Carolina | |
| Call for Information (Investigational Site 0031) | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Brazil | |
| MSD Brasil | Recruiting |
| Sao Paulo, Brazil | |
| Contact: Ricardo Germano 55 11 51897942 | |
| Colombia | |
| MDS Colombia SAS | Recruiting |
| Bogota, Colombia | |
| Contact: Francesca Carvajal 57 1219109011090 | |
| France | |
| MSD France | Recruiting |
| Paris, France | |
| Contact: Dominique Blazy 33 147548990 | |
| Germany | |
| Merck Sharp & Dohme GmbH | Recruiting |
| Haar, Germany | |
| Contact: Kristian Lobner 49 89 4561 1102 | |
| Hungary | |
| MSD Pharma Hungary Kft. | Recruiting |
| Budapest, Hungary | |
| Contact: Simona Martinkova 36 1 457 8522 | |
| Israel | |
| Merck Sharp & Dohme Co. Ltd. | Recruiting |
| Hod Hasharon, Israel | |
| Contact: Ofer Sharon 972�9 9539310 | |
| Mexico | |
| MSD | Recruiting |
| Mexico City, Mexico | |
| Contact: Jose Gregorio Quijada 555 481 9608 | |
| Norway | |
| MSD Norge A/S | Recruiting |
| Drammen, Norway | |
| Contact: Jon Sigurd Riis 47 32207465 | |
| Peru | |
| Merck Sharp & Dohme, Peru S.R.L. | Recruiting |
| Lima, Peru | |
| Contact: Oscar Espinoza (51-1) 411-5100 | |
| Poland | |
| MSD Polska Sp. Z o.o. | Recruiting |
| Warsaw, Poland | |
| Contact: Adam Czernik 48 22 4784324 | |
| Spain | |
| Merck Sharp and Dohme de Espana S.A. | Recruiting |
| Madrid, Spain | |
| Contact: Cesar Sanz Rodriguez 34 913210600 | |
| Sweden | |
| MSD | Recruiting |
| Sollentuna, Sweden | |
| Contact: Tryggve Ljung 46 (0)70 545 28 66 | |
| Switzerland | |
| MSD International GmbH | Recruiting |
| Lucerne 6, Switzerland | |
| Contact: Christiane Andrea Belly 41 58 618 15 99 | |
Sponsors and Collaborators
Merck
Investigators
| Study Director: | Medical Monitor | Merck |
More Information
Additional Information:
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00818259 History of Changes |
| Other Study ID Numbers: | 0869-134, 2009_501 |
| Study First Received: | January 6, 2009 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vomiting Signs and Symptoms, Digestive Signs and Symptoms Ondansetron Aprepitant Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 19, 2013