NCT01596413撤回1 期
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 6 to 12 Years)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Plasma concentration
研究概览
简要总结
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
详细描述
This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 6 to 12 years of age 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 granisetron (Sancuso® patch) in a pediatric population (aged 6 to 12 years), using a population PK approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 12 years of age inclusive at screening.
- •Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
- •Written patient assent (as appropriate).
- •Confirmed malignancy.
- •Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
- •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.
排除标准
- •Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
- •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.
- •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.
- •Patients scheduled to have routine surgery during the study duration.
- •Patients with a life expectancy of < 6 months.
- •Scarring or significant skin disease on both upper arms.
- •Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
- •Patients who are known or thought to be sexually active must use effective birth control.**
- •Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
- •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.
研究组 & 干预措施
Sancuso Arm
Experimental
Transdermal Patch 34.3mg graniestron per patch, size 52cm2 Dose: 3.1mg/24 hrs
干预措施: Sancuso (Drug)
IV Granisetron
Active Comparator
Aqueous solution for IV administration
1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg)
干预措施: IV granisetron (Drug)
结局指标
主要结局
Plasma concentration
时间窗: Up to 7 days
Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
次要结局
- Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy(From screening until 15 days after the last dose of IV granisetron)
- Number of participants with change in ECG parameters(Through study completion, an average of 8 weeks)
- Number of participants with change in vital signs(Through study completion, an average of 8 weeks)
- Number of participants with change in physical assessment including height, weight, BMI and BSA(Through study completion, an average of 8 weeks)
研究者
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