Chemotherapy Induced Nausea and Vomiting
Conditions
Keywords
CINV
Brief summary
The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.
Detailed description
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.
Interventions
DRUGSancuso
granisetron transdermal system
DRUGIV granisetron
IV granisetron
Sponsors
Kyowa Kirin Pharmaceutical Development Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
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.
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 |
|---|---|---|
| Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy | Through study completion, an average of 8 weeks | Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment |
| Number of participants with change in physical assessment including height, weight, BMI and BSA | Through study completion, an average of 8 weeks | Change in height and weight to calculate BMI and BSA |
| Number of participants with change in vital signs | Through study completion, an average of 8 weeks | Change in pulse, systolic and diastolic blood pressure measurements |
| Number of participants with change in ECG parameters | Through study completion, an average of 8 weeks | 12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest |
Outcome results
None listed