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

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)

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy Induced Nausea and Vomiting
• Intervention / Treatment: Drug: granisetron transdermal system; Drug: Granisetron IV

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1690
      • David Geffen School of Medicine at UCLA
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado, Center for Cancer and Blood Disorders
  • Florida
    • Gainesville, Florida, United States, 32610-0296
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic
    • Tampa, Florida, United States, 33606
      • University Of South Florida
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT southwestern Medical Center
    • Dallas, Texas, United States, 75390-9063
      • UTSW/Childrens Medical Center
  • Washington
    • Spokane, Washington, United States, 99201
      • Providence Sacred Heart Medical Center and Children's Hospital
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sancuso Arm	Drug: granisetron transdermal system; patch; Other Names: Sancuso
Active Comparator: IV Granisetron Arm; IV	Drug: Granisetron IV; IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration	Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chang is Safety from baseline	Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)	Up to 7 days

Collaborators and Investigators

• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimated): May 11, 2012

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: CINV
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Granisetron
• Other Study ID Numbers: 392MD/44/C