Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years

An Open-label, Cross-over, Pharmacokinetic Study to Assess the Safety and Pharmacokinetics of Transdermal Granisetron (Sancuso® Patch) and IV Granisetron in a Pediatric Oncology Population (Aged 2 to 5 Years)

The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.

Study Overview

• Status: Withdrawn
• Conditions: Chemotherapy Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Sancuso; Drug: IV granisetron

Detailed Description

This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 2 to 5 years 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 granisteron (Sancuso(R) patch) in a pediatric population (aged 2 to 5 years) using a population PK approach.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 2 to 5 years of age inclusive at screening.
2. Written parental (or appropriate legal representative) IRB approved informed consent as appropriate.
3. Confirmed malignancy.
4. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.

5. 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. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
8. Any conditions associated with non-compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sancuso Arm; patch	Drug: Sancuso; granisetron transdermal system
Active Comparator: IV granisetron; IV	Drug: IV granisetron; IV granisetron; Other Names: IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy	Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment	Through study completion, an average of 8 weeks
Number of participants with change in physical assessment including height, weight, BMI and BSA	Change in height and weight to calculate BMI and BSA	Through study completion, an average of 8 weeks
Number of participants with change in vital signs	Change in pulse, systolic and diastolic blood pressure measurements	Through study completion, an average of 8 weeks
Number of participants with change in ECG parameters	12 lead ECGs will be conducted to time match PK samples after at least 5 minutes supine rest	Through study completion, an average of 8 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Study record dates

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: CINV
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: 392MD/47/C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No