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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Chemotherapy Induced Nausea and Vomiting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sancuso Arm

Group Type EXPERIMENTAL

granisetron transdermal system

Intervention Type DRUG

patch

IV Granisetron Arm

IV

Group Type ACTIVE_COMPARATOR

Granisetron IV

Intervention Type DRUG

IV

Interventions

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granisetron transdermal system

patch

Intervention Type DRUG

Granisetron IV

IV

Intervention Type DRUG

Other Intervention Names

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Sancuso

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No