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Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

Sponsor
Kyowa Kirin Pharmaceutical Development Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01596400
Collaborator
(none)
19
Enrollment
12
Locations
2
Arms
55
Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

Condition or Disease Intervention/Treatment Phase
  • Drug: granisetron transdermal system
  • Drug: Granisetron IV
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 13 to 17 Years)
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sancuso Arm

Drug: granisetron transdermal system
patch
Other Names:
  • Sancuso

    		•
    Active Comparator: IV Granisetron Arm

    IV

    Drug: Granisetron IV
    IV

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentration [Up to 7 days]

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

    Secondary Outcome Measures

    1. Safety [Up to 7 days]

      Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 13 to 17 years of age inclusive at screening.

    2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.

    3. Written patient assent (as appropriate).

    4. Confirmed malignancy.

    5. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.

    6. 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. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.

    8. Patients who are known or thought to be sexually active must use effective birth control.**

    9. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.

    10. Any conditions associated with non-compliance.

    • Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David Geffen School of Medicine at UCLA Los Angeles California United States 90095-1690
    2 Children's Hospital of Orange County Orange California United States 92868
    3 Children's Hospital Colorado, Center for Cancer and Blood Disorders Aurora Colorado United States 80045
    4 University of Florida Gainesville Florida United States 32610-0296
    5 Nemours Children's Clinic Jacksonville Florida United States 32207
    6 University of South Florida Tampa Florida United States 33606
    7 University of Mississippi Medical Center Jackson Mississippi United States 39216
    8 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    9 UTSW/Childrens Medical Center Dallas Texas United States 75390-9063
    10 UT Southwestern Medical Center Dallas Texas United States 75390
    11 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99201
    12 Madigan Army Medical Center Tacoma Washington United States 98431

    Sponsors and Collaborators

    • Kyowa Kirin Pharmaceutical Development Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Kirin Pharmaceutical Development Ltd
    ClinicalTrials.gov Identifier:
    NCT01596400
    Other Study ID Numbers:
    • 392MD/44/C
    First Posted:
    May 11, 2012
    Last Update Posted:
    Jul 13, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Kyowa Kirin Pharmaceutical Development Ltd
    CINV
    Additional relevant MeSH terms:
    Vomiting
    Granisetron

    Study Results

    No Results Posted as of Jul 13, 2017