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Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years

This study is not yet open for participant recruitment.
Verified June 2017 by Kyowa Kirin Pharmaceutical Development Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596413
First Posted: May 11, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd
  Purpose
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.

Condition Intervention Phase
Chemotherapy Induced Nausea and Vomiting Drug: Sancuso Drug: IV granisetron Phase 1

Study Type: Interventional
Study Design: 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 6 to 12 Years)

Resource links provided by NLM:


Further study details as provided by Kyowa Kirin Pharmaceutical Development Ltd:

Primary Outcome Measures:
  • Plasma concentration [ Time Frame: 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:
  • Safety [ Time Frame: Up to 7 days ]
    Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)


Estimated Enrollment: 16
Arms Assigned Interventions
Experimental: Sancuso Arm
patch
Drug: Sancuso
granisetron transdermal system
Active Comparator: IV Granisetron
IV
Drug: IV granisetron
IV
Other Name: IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 6 to 12 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596413


Contacts
Contact: Alexandre Andre +44 (0) 1896 664000 alexandre.andre@kyowakirin.com

Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
  More Information

Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT01596413     History of Changes
Other Study ID Numbers: 392MD/46/C
First Submitted: April 26, 2012
First Posted: May 11, 2012
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Kyowa Kirin Pharmaceutical Development Ltd:
CINV

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action