Clinical trial · Interventional
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years
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 2 to 5 Years)
NCT01596426CI-TRIAL-00079148withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The company currently does not have plans to conduct this study
Summary
Brief summary (as posted)
The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV granisetron | Drug | — | UNRESOLVED |
| Sancuso | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sancuso Arm
- description
- patch
- interventionNames
- Drug: Sancuso
- type
- ACTIVE_COMPARATOR
- label
- IV granisetron
- description
- IV
- interventionNames
- Drug: IV granisetron
Primary outcomes (1)
- measure
- Plasma concentration
- timeFrame
- Up to 7 days
- description
- Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.