This trial is active, not recruiting.

Condition chemotherapy induced nausea and vomiting
Treatments granisetron transdermal system, granisetron iv
Phase phase 1
Sponsor Prostrakan Pharmaceuticals
Start date May 2012
End date May 2016
Trial size 16 participants
Trial identifier NCT01596400, 392MD/44/C


The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

United States No locations recruiting
Other Countries

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
granisetron transdermal system Sancuso
(Active Comparator)
granisetron iv

Primary Outcomes

Plasma concentration
time frame: Up to 7 days

Secondary Outcomes

time frame: Up to 7 days

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

Inclusion Criteria: 1. 13 to 17 years of age inclusive at screening. 2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate. 3. Written patient assent (as appropriate). 4. Confirmed malignancy. 5. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment. 6. 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. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening. 8. Patients who are known or thought to be sexually active must use effective birth control.** 9. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments. 10. 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.

Additional Information

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 13 to 17 Years)
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Prostrakan Pharmaceuticals.
Location data was received from the National Cancer Institute and was last updated in February 2016.