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

NCT01596413 | Withdrawn Phase 1

• 1 other identifier: 392MD/46/C
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 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 (4)

• Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy

  From screening until 15 days after the last dose of IV granisetron

• Number of participants with change in physical assessment including height, weight, BMI and BSA

  Through study completion, an average of 8 weeks

• Number of participants with change in vital signs

  Through study completion, an average of 8 weeks

• Number of participants with change in ECG parameters

  Through study completion, an average of 8 weeks

Study Arms (2)

Sancuso Arm

EXPERIMENTAL

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

Drug: Sancuso

IV Granisetron

ACTIVE COMPARATOR

Aqueous solution for IV administration 1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg)

Drug: IV granisetron

Interventions

Sancuso DRUG

granisetron transdermal system

Sancuso Arm

IV granisetron DRUG

IV

Also known as: IV

IV Granisetron

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 12 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

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
• Last Updated: July 26, 2024

Record last verified: 2024-07