Efficacy of Aprepitant (Emend®) in Children

NCT01661335 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 0413
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.

Conditions

Nausea; Vomiting; Childhood Cancer

Keywords

Nausea; Vomiting; Children; Aprepitant; Emend®

Outcome Measures

Primary Outcomes (4)

• Efficacy of aprepitant (Emend®) measured through a complete response

  • Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.

  Up to 11 weeks, or until 3 weeks after the second course of the study regimen

• Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.

  * The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle. * The total number of administrations of rescue medications given for breakthrough nausea or vomiting.

  Up to 11 weeks, or until 3 weeks after the second course of the study regimen

• Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life

  • A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire

  Up to 11 weeks, or until 3 weeks after the second course of the study regimen

• Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale

  • A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.

  Up to 11 weeks, or until 3 weeks after the second course of the study regimen

Secondary Outcomes (1)

• Safety of aprepitant (Emend®)

  Up to 11 weeks, or until 3 weeks after the second course of the study regimen

Study Arms (2)

Ondansetron, dexamethasone, aprepitant

EXPERIMENTAL

Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.

Drug: Ondansetron, dexamethasone, aprepitant

Ondansetron, Dexamethasone, placebo

PLACEBO COMPARATOR

Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.

Drug: Ondansetron, Dexamethasone, placebo

Interventions

Ondansetron, dexamethasone, aprepitant DRUG

Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.

Also known as: Aprepitant = Emend, ARM A

Ondansetron, dexamethasone, aprepitant

Ondansetron, Dexamethasone, placebo DRUG

Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.

Also known as: ARM B

Ondansetron, Dexamethasone, placebo

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• under 20.99 years of age at enrollment
• Scheduled to receive two identical cycles of highly emetogenic\[1\] chemotherapy for treatment of a primary malignancy, including:
• Chemotherapy with any one or more of the following single agents in any combination:
• Carboplatin
• Carmustine \>250 mg/m2
• Cisplatin
• Cyclophosphamide ≥1 g/m2
• Dactinomycin
• High dose Methotrexate ≥ 5 g/m2
• Or any of the following defined combinations:
• Cyclophosphamide + anthracycline
• Cyclophosphamide + etoposide
• Cytarabine 150-200 mg/m2 + daunorubicin
• Cytarabine 300 mg/m2 + etoposide
• Cytarabine 300 mg/m2 + teniposide

You may not qualify if:

• Patients who have received aprepitant in the past.
• Patients who demonstrate evidence of increased intracranial pressure.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Jimmy Everest Center for Cancer and Blood Disorders in Children

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting; Neoplasms

Interventions

Ondansetron; Dexamethasone; Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Morpholines; Oxazines

Study Officials

• Rene McNall-Knapp, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: August 9, 2012
• Study Start: June 1, 2012
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)