Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years
Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chemotherapy Induced Nausea and Vomiting
Intervention: Sancuso (Drug); IV granisetron (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Prostrakan Pharmaceuticals Overall contact: Liz Emmerson, Phone: +44 (0) 1896 664000, Email: liz.emmerson@prostrakan.com
Summary
The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5
years.
Clinical Details
Official title: 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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma concentration
Secondary outcome: Safety
Eligibility
Minimum age: 2 Years.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Liz Emmerson, Phone: +44 (0) 1896 664000, Email: liz.emmerson@prostrakan.com Additional Information
Starting date: July 2014
Last updated: January 23, 2014
|