Clinical trial NCT01596400: Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy Induced Nausea and Vomiting
Keywords: CINV
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-11
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Plasma concentration
timeFrame: Up to 7 days
Secondary outcomes:
measure: Chang is Safety from baseline
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado, Center for Cancer and Blood Disorders
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UTSW/Childrens Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: