Chemotherapy Induced Nausea and VomitingPhase 1NCT01596413
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
A Phase 1 study testing Sancuso and IV granisetron in people with Chemotherapy Induced Nausea and Vomiting, run by Kyowa Kirin Pharmaceutical Development Ltd.
Trial summary
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- Sancuso and IV granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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 6 to 12 Years)
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
Read the 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
- Being tested
- Sancuso, IV granisetron
- Keywords
- CINV
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SancusoDrug
granisetron transdermal system
IV granisetronDrug
Also called IV
IV
| Study group | Role | What they receive |
|---|---|---|
| Sancuso Arm | Experimental | Transdermal Patch 34.3mg graniestron per patch, size 52cm2 Dose: 3.1mg/24 hrs Receives: Drug: Sancuso |
| IV Granisetron | Active comparator | Aqueous solution for IV administration
1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg) Receives: Drug: IV granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration
Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
Measured: 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
Incidence, frequency, and severity of AEs and SAEs, including clinically significant changes in laboratory assessments and application site assessment.
Measured: 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
Change in height and weight to calculate BMI and BSA
Measured: Through study completion, an average of 8 weeks
Number of participants with change in vital signs
Change in pulse, systolic and diastolic blood pressures measurements
Measured: 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
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
Why it stopped: The company currently does not have plans to conduct this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596413
- Sponsor's protocol ID
- 392MD/46/C
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2012
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 6 to 12 Years)
- ClinicalTrials.gov ID
- NCT01596413
- Acronym / sponsor ID
- 392MD/46/C
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Keywords
- CINV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company currently does not have plans to conduct this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sancuso Arm | Experimental | Drug: SancusoTransdermal Patch 34.3mg graniestron per patch, size 52cm2 Dose: 3.1mg/24 hrs |
| IV Granisetron | Active comparator | Drug: IV granisetronAqueous solution for IV administration 1 mg/mL ampoules Dose: 0.01mg/kg (maximum 1 mg) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sancusogranisetron transdermal system | Drug | Sancuso Arm |
| IV granisetronAlso: IVIV | Drug | IV Granisetron |
Primary outcome
Plasma concentration
Time frame: Up to 7 days
Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.
4 secondary outcomes
Number of participants with adverse events, application site assessment and clinically significant changes in laboratory assessments over 2 cycles of chemotherapy
Time frame: 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
Time frame: Through study completion, an average of 8 weeks
Number of participants with change in vital signs
Time frame: Through study completion, an average of 8 weeks
Number of participants with change in ECG parameters
Time frame: Through study completion, an average of 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sancuso and IV granisetron in people with Chemotherapy Induced Nausea and Vomiting, run by Kyowa Kirin Pharmaceutical Development Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.