Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years

NCT ID: NCT01596413

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.

Detailed Description

This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 6 to 12 years of age who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisetron (Sancuso® patch) in a pediatric population (aged 6 to 12 years), using a population PK approach.

Conditions

Chemotherapy Induced Nausea and Vomiting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sancuso Arm

Transdermal Patch 34.3mg graniestron per patch, size 52cm2 Dose: 3.1mg/24 hrs

Group Type: EXPERIMENTAL

Sancuso

Intervention Type: DRUG

granisetron transdermal system

IV Granisetron

Aqueous solution for IV administration

1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg)

Group Type: ACTIVE_COMPARATOR

IV granisetron

Intervention Type: DRUG

IV

Interventions

Sancuso

granisetron transdermal system

Intervention Type: DRUG

IV granisetron

IV

Intervention Type: DRUG

Other Intervention Names

IV

Eligibility Criteria

Inclusion Criteria

1. 6 to 12 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: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Pharmaceutical Development Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

392MD/46/C

Identifier Type: -

Identifier Source: org_study_id