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

NCT01596400 | Completed Phase 1

• 1 other identifier: 392MD/44/C
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Chemotherapy Induced Nausea and Vomiting

Keywords

CINV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Chang is Safety from baseline

  Up to 7 days

Study Arms (2)

Sancuso Arm

EXPERIMENTAL

Drug: granisetron transdermal system

IV Granisetron Arm

ACTIVE COMPARATOR

IV

Drug: Granisetron IV

Interventions

granisetron transdermal system DRUG

patch

Also known as: Sancuso

Sancuso Arm

Granisetron IV DRUG

IV

IV Granisetron Arm

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Pharmaceutical Development Ltd: lead

Study Sites (12)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-1690, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's Hospital Colorado, Center for Cancer and Blood Disorders

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610-0296, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UTSW/Childrens Medical Center

Dallas, Texas, 75390-9063, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99201, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 11, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

US (12)