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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00080444
First received: March 31, 2004
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Vomiting
Drug: aprepitant
Drug: ondansetron
Drug: dexamethasone
Drug: placebo to aprepitant
Drug: placebo to dexamethasone
Drug: rescue medication
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience Absence of Nausea (Cycle 1) [ Time Frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience Absence of Vomiting (Cycle 1) [ Time Frame: Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1) [ Time Frame: Up to Day 4 of Cycle 1 ] [ Designated as safety issue: Yes ]
  • Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics [ Time Frame: Up to 24 hours after first dose of aprepitant ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2004
Study Completion Date: March 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Aprepitant
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: aprepitant
aprepitant capsules
Drug: ondansetron
ondansetron IV preparation
Drug: dexamethasone
dexamethasone tablets
Drug: placebo to dexamethasone
Matching placebo to dexamethasone tablets
Drug: 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.
Active Comparator: Part 1: Standard Therapy
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: ondansetron
ondansetron IV preparation
Drug: dexamethasone
dexamethasone tablets
Drug: placebo to aprepitant
Matching placebo to aprepitant capsules
Drug: 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.
Active Comparator: Part 2: Aprepitant
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: aprepitant
aprepitant capsules
Drug: ondansetron
ondansetron IV preparation
Drug: dexamethasone
dexamethasone tablets
Drug: placebo to dexamethasone
Matching placebo to dexamethasone tablets
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080444

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00080444     History of Changes
Other Study ID Numbers: 0869-097, Formerly-0304AHEC, MK-0869-097, 2004_099
Study First Received: March 31, 2004
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Aprepitant
Fosaprepitant
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Antipruritics

ClinicalTrials.gov processed this record on September 30, 2014