Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

Chemotherapy Induced Nausea and Vomiting Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596400
• Other study ID #: 392MD/44/C
• Status: Completed
• Phase: Phase 1
• Start date: May 2012
• Est. completion date: December 2016

Study information

• Verified date: June 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Induced Nausea and Vomiting
• Vomiting

Intervention

Drug:
• granisetron transdermal system
patch
• Granisetron IV
IV

Locations

Country	Name	City	State
United States	Children's Hospital Colorado, Center for Cancer and Blood Disorders	Aurora	Colorado
United States	UT Southwestern Medical Center	Dallas	Texas
United States	UTSW/Childrens Medical Center	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Children's Hospital of Orange County	Orange	California
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Pharmaceutical Development Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration	Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.	Up to 7 days
Secondary	Chang is Safety from baseline	Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)	Up to 7 days