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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

Page last updated: August 23, 2015

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