Safety and Pharmacokinetics of Sancuso and IV Granisetron... | NCT01596426

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

NCT01596426

Sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Status

Withdrawn

Last Update Posted

Jul 26, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Chemotherapy Induced Nausea and Vomiting

Interventions

Sancuso
IV granisetron

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The company currently does not have plans to conduct this study

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 26, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2024

Last Update Posted Date

Jul 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Sancuso Arm	Experimental	patch	Drug: Sancuso
IV granisetron	Active Comparator	IV	Drug: IV granisetron

Name	Type	Description	Arm Group Labels	Other Names
Sancuso	Drug	granisetron transdermal system	Sancuso Arm
IV granisetron

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

2 to 5 years of age inclusive at screening.
Written parental (or appropriate legal representative) IRB approved informed consent 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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D007191	Indazoles