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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Prostrakan Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01596400
First received: April 26, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Chemotherapy Induced Nausea and Vomiting
Drug: granisetron transdermal system
Drug: Granisetron IV
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:
  • Plasma concentration [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)


Estimated Enrollment: 16
Study Start Date: May 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sancuso Arm Drug: granisetron transdermal system
patch
Other Name: Sancuso
Active Comparator: IV Granisetron Arm
IV
Drug: Granisetron IV
IV

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01596400

Contacts
Contact: Liz Emmerson +44 (0) 1896 664000 liz.emmerson@prostrakan.com

Locations
United States, Washington
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99201
Sponsors and Collaborators
Prostrakan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01596400     History of Changes
Other Study ID Numbers: 392MD/44/C
Study First Received: April 26, 2012
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Prostrakan Pharmaceuticals:
CINV

Additional relevant MeSH terms:
Granisetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014