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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2014 by Prostrakan Pharmaceuticals.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals Identifier:
First received: April 26, 2012
Last updated: January 23, 2014
Last verified: January 2014
The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.

Condition Intervention Phase
Chemotherapy Induced Nausea and Vomiting
Drug: Sancuso
Drug: IV granisetron
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 2 to 5 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: July 2014
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sancuso Arm
Drug: Sancuso
granisetron transdermal system
Active Comparator: IV granisetron
Drug: IV granisetron
IV granisetron
Other Name: IV


Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT01596426

Contact: Liz Emmerson +44 (0) 1896 664000

Sponsors and Collaborators
Prostrakan Pharmaceuticals
  More Information

Responsible Party: Prostrakan Pharmaceuticals Identifier: NCT01596426     History of Changes
Other Study ID Numbers: 392MD/47/C 
Study First Received: April 26, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Prostrakan Pharmaceuticals:

Additional relevant MeSH terms:
Autonomic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists processed this record on May 26, 2016