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Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years

Primary Purpose

Chemotherapy Induced Nausea and Vomiting

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sancuso
IV granisetron
Sponsored by
Kyowa Kirin Pharmaceutical Development Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Nausea and Vomiting focused on measuring CINV

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 2 to 5 years of age inclusive at screening.
  2. Written parental (or appropriate legal representative) IRB approved informed consent as appropriate.
  3. Confirmed malignancy.
  4. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.

  5. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

    • The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria:

  1. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
  2. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
  3. Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
  4. Patients scheduled to have routine surgery during the study duration.
  5. Patients with a life expectancy of <6 months.
  6. Scarring or significant skin disease on both upper arms.
  7. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
  8. Any conditions associated with non-compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sancuso Arm

    IV granisetron

    Arm Description

    patch

    IV

    Outcomes

    Primary Outcome Measures

    Plasma concentration
    Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.

    Secondary Outcome Measures

    Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy
    Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment
    Number of participants with change in physical assessment including height, weight, BMI and BSA
    Change in height and weight to calculate BMI and BSA
    Number of participants with change in vital signs
    Change in pulse, systolic and diastolic blood pressure measurements
    Number of participants with change in ECG parameters
    12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest

    Full Information

    First Posted
    April 26, 2012
    Last Updated
    March 18, 2021
    Sponsor
    Kyowa Kirin Pharmaceutical Development Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01596426
    Brief Title
    Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years
    Official Title
    An Open-label, Cross-over, Pharmacokinetic Study to Assess the Safety and Pharmacokinetics of Transdermal Granisetron (Sancuso® Patch) and IV Granisetron in a Pediatric Oncology Population (Aged 2 to 5 Years)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The company currently does not have plans to conduct this study
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kyowa Kirin Pharmaceutical Development Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.
    Detailed Description
    This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy Induced Nausea and Vomiting
    Keywords
    CINV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sancuso Arm
    Arm Type
    Experimental
    Arm Description
    patch
    Arm Title
    IV granisetron
    Arm Type
    Active Comparator
    Arm Description
    IV
    Intervention Type
    Drug
    Intervention Name(s)
    Sancuso
    Intervention Description
    granisetron transdermal system
    Intervention Type
    Drug
    Intervention Name(s)
    IV granisetron
    Other Intervention Name(s)
    IV
    Intervention Description
    IV granisetron
    Primary Outcome Measure Information:
    Title
    Plasma concentration
    Description
    Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
    Time Frame
    Up to 7 days
    Secondary Outcome Measure Information:
    Title
    Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy
    Description
    Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Number of participants with change in physical assessment including height, weight, BMI and BSA
    Description
    Change in height and weight to calculate BMI and BSA
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Number of participants with change in vital signs
    Description
    Change in pulse, systolic and diastolic blood pressure measurements
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Number of participants with change in ECG parameters
    Description
    12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest
    Time Frame
    Through study completion, an average of 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 2 to 5 years of age inclusive at screening. Written parental (or appropriate legal representative) IRB approved informed consent as appropriate. Confirmed malignancy. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis. The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment. Exclusion Criteria: Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study. Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval. Patients scheduled to have routine surgery during the study duration. Patients with a life expectancy of <6 months. Scarring or significant skin disease on both upper arms. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments. Any conditions associated with non-compliance.

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years

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