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

Completed · Phase 1

Conditions studied: Chemotherapy Induced Nausea and Vomiting

In brief

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

Key facts

Study ID

NCT01596400

Run by

Kyowa Kirin Pharmaceutical Development Ltd

People needed

19

Starts

2012-05-01

Expected to finish

2016-12-01

Last updated by the study team

2024-06-17

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 13 to 17 years of age inclusive at screening.
• Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
• Written patient assent (as appropriate).
• Confirmed malignancy.
• Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
• 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.

You may not qualify if…

• Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
• 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.
• 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.
• Patients scheduled to have routine surgery during the study duration.
• Patients with a life expectancy of < 6 months.
• Scarring or significant skin disease on both upper arms.
• Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
• Patients who are known or thought to be sexually active must use effective birth control.**
• Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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