Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years (NCT01596413) | Clinical Trial Compass
WithdrawnPhase 1
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
Stopped: The company currently does not have plans to conduct this study
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Plain-language summary
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.