Chemotherapy Induced Nausea and Vomiting
Conditions
Keywords
CINV
Brief summary
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
Interventions
patch
DRUGGranisetron IV
IV
Sponsors
Kyowa Kirin Pharmaceutical Development Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | 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
| Measure | Time frame | Description |
|---|---|---|
| Chang is Safety from baseline | Up to 7 days | Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) |
Countries
United States
Outcome results
None listed