Chemotherapy Induced Nausea and VomitingPhase 1NCT01596400
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years
A Phase 1 study testing granisetron transdermal system and Granisetron IV in people with Chemotherapy Induced Nausea and Vomiting, run by Kyowa Kirin Pharmaceutical Development Ltd at 12 sites in United States.
Trial summary
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- granisetron transdermal system and Granisetron IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2012to Dec 2016
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13 to 17 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Children's Hospital Colorado, Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
UTSW/Childrens Medical Center
Dallas, Texas, 75390-9063
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610-0296
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Nemours Children's Clinic
Jacksonville, Florida, 32207
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1690
Children's Hospital of Orange County
Orange, California, 92868
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99201
Madigan Army Medical Center
Tacoma, Washington, 98431
University of South Florida
Tampa, Florida, 33606
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 13 to 17 Years)
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- granisetron transdermal system, Granisetron IV
- 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.
granisetron transdermal systemDrug
Also called Sancuso
patch
Granisetron IVDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Sancuso Arm | Experimental | Not described Receives: Drug: granisetron transdermal system |
| IV Granisetron Arm | Active comparator | IV Receives: Drug: Granisetron IV |
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 (1)
Chang is Safety from baseline
Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)
Measured: Up to 7 days
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)
- Study startMay 2012
- Primary completionAug 2015
- Study completionDec 2016
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
- 19 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
- NCT01596400
- Sponsor's protocol ID
- 392MD/44/C
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2012
- Last updated
- 17 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 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 13 to 17 Years)
- ClinicalTrials.gov ID
- NCT01596400
- Acronym / sponsor ID
- 392MD/44/C
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Keywords
- CINV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2016 (actual)
- 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 13 to 17 years.
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: granisetron transdermal system |
| IV Granisetron Arm | Active comparator | Drug: Granisetron IVIV |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 13 to 17 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 |
|---|---|---|
| granisetron transdermal systemAlso: Sancusopatch | Drug | Sancuso Arm |
| Granisetron IVIV | Drug | IV Granisetron Arm |
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.
1 secondary outcome
Chang is Safety from baseline
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing granisetron transdermal system and Granisetron IV in people with Chemotherapy Induced Nausea and Vomiting, run by Kyowa Kirin Pharmaceutical Development Ltd at 12 sites in United States.
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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 17 Jun 2024.