Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)Phase 4NCT01662687
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in CINV (Chemotherapy-induced Nausea and Vomiting) Associated With the Administration of MEC (Moderately Emetogenic Chemotherapy)
A Phase 4 study testing Sancuso patch and Kytril inj.+Kytril tab. in people with Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV), run by LG Life Sciences at 1 site in South Korea.
Trial summary
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
- What is being tested?
- Sancuso patch and Kytril inj.+Kytril tab.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged over 20 yrs
- Histologically and/or cytologically proven cancer patients
- Eastern Cooperative Oncology Group performance status 0, 1, 2
- A cycle of moderately emetogenic chemotherapy(NCCN Guidelines)
- Life expectancy of ≥ 3 months
- Normal liver function and renal function(total bilirubin ≤ 1.5 ULN, AST/ALT ≤ 2.5 ULN, in case of liver metastases AST/ALT ≤ 5 ULN, serum creatinine ≤ 1.5 ULN) patients
- Patients who signed the informed consent form
Who cannot join
- Previous History
- Hypersensitivity to adhesive plasters
- Contraindications to 5-HT3 receptor antagonists
- Any other relevant medical history (at the discretion of the investigator)
- Concomitant Medical Condition
- Current alcohol, drug or medication abuse
Show all 23Show fewer
- Currently pregnant or breast feeding women, including planning pregnancy
- Clinically relevant abnormal laboratory values (at the discretion of the investigator)
- Clinically relevant heart, hepatic, renal, infectious, neurological or psychiatric disorders, or any other major systemic illness (at the discretion of the investigator)
- Any cause for nausea and vomiting other than CINV
- Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to the chemotherapy administration
- Clinically relevant abnormal ECG parameters (at the discretion of the investigator)
- Concomitant Therapy/Medication
- Concomitant radiotherapy of total body, brain or upper abdomen within one week prior to the study entry or planned during the study
- Intake of medication to control the symptoms of a brain tumor, brain metastasis or seizure disorder or neuropathy (unless peripheral neuropathy at the discretion of the investigator)
- Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a stable dose for the duration of the study)
- Receipt of a narcotic analgesics (acceptable at the discretion of the investigator)
- Receipt of any other clinical trial drug < 30 days before the study or during the study
- Scheduled to receive a neurokinin NK1 receptor antagonist, dopamine receptor antagonist or another 5-HT3 receptor antagonist at 72 h prior to the administration of the chemotherapy or scheduled to do those medication during chemotherapy duration
- Drugs known to increase the QTc interval (unless a stable dose for the duration of the study at the discretion of the investigator)
- Other
- Patients unlikely to comply with the study protocol (at the discretion of the investigator), e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
- The patch adhesion level was not more than 50% on the day of chemotherapy or the patch was not attached within two days before the chemotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Jin Seok Ahn, MD, PhD, 82-2-3410-3453, ajis@skku.edu
Jin Seok Ahn, MD, PhD
About this study
Official title: Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy.
Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to ME chemotherapy).
Read more
- Sancuso patch
- Kytril inj.+Kytril tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the moderately emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until 14 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.
- Being tested
- Sancuso patch, Kytril inj.+Kytril tab.
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sancuso patchDrug
Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy.
Kytril inj.+Kytril tab.Drug
Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
Active Comparator arm:
- Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1).
- Kytril tab. 1mg: administered twice a day by orally at Day 2~4.
| Study group | Role | What they receive |
|---|---|---|
| Sancuso patch | Experimental | Not described Receives: Drug: Sancuso patch |
| Kytril | Active comparator | Not described Receives: Drug: Kytril inj.+Kytril tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Secondary outcomes (12)
The percentage of patients achieving Complete Response (CR)
Measured: overall (Day 1~4)
The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
The percentage of patients achieving Complete Control (CC)
Measured: overall (Day 1~4)
severity of nausea
Measured: overall (Day 1~4)
severity of vomiting
Measured: overall (Day 1~4)
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Measured: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5)
The patient's response to anti-emetic therapy was assessed and recorded by patients at Visit 3 (Baseline) and Visit 7 (Day 5). The patient was asked to evaluate his/her satisfaction with the control of nausea and vomiting by marking the FLI-E (Functional Living Index - Emesis) with vertical lines.
Measured: from baseline to Day 5
The percentage of patients achieving Complete Response (CR)
Measured: per day (Day 1, 2, 3, 4)
The percentage of patients achieving Complete Control (CC)
Measured: per day (Day 1, 2, 3, 4)
severity of nausea
Measured: per day (Day 1, 2, 3, 4)
severity of vomiting
Measured: per day (Day 1, 2, 3, 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Seok Ahn, MD, PhD, Principal investigator, Samsung Medical CenterTae Won Kim, MD, PhD, Principal investigator, Asan Medical CenterDong Bok Shin, MD, PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662687
- Sponsor's protocol ID
- LG-SCSCL002
- Status last verified
- Aug 2012
- First submitted
- 8 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JE, Hong YS, Lee JL, Kim KP, Park SJ, Sym SJ, Shin DB, Lee J, Park YS, Ahn JS, Kim TW. A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Support Care Cancer. 2015 Jun;23(6):1769-77. doi: 10.1007/s00520-014-2507-6. Epub 2014 Dec 3.
PubMed 25465680
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Efficacy and Safety of Transdermal Granisetron Compared With Intravenous and Oral Agent in the Control of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT01662687
- Acronym / sponsor ID
- LG-SCSCL002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 10 Aug 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.
Multicenter, randomized, open-label, paralled-group, active-controlled study. The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV associated with moderately emetogenic Chemotherapy.
Patients scheduled to receive the one cycle of a ME chemotherapy regimen administered for 1-4 days will attend a Screening Visit 2 to 28 days before start of ME chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to ME chemotherapy).
- Sancuso patch
- Kytril inj.+Kytril tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the moderately emetogenic chemotherapy regimen and remain in place for 6 days. The patient will be assessed daily until 4days after first chemotherapy administration. Adverse Events (AEs) will be collected until 14 days after the final dose of IP. Non-serious AEs will be followed-up until 14 days after the final dose of IP. Serious adverse events will be followed-up until they are resolved, stable or until the patient is lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sancuso patch | Experimental | Drug: Sancuso patch |
| Kytril | Active comparator | Drug: Kytril inj.+Kytril tab. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged over 20 yrs
- Histologically and/or cytologically proven cancer patients
- Eastern Cooperative Oncology Group performance status 0, 1, 2
- A cycle of moderately emetogenic chemotherapy(NCCN Guidelines)
- Life expectancy of ≥ 3 months
Key exclusion criteria (23 listed)
- Previous History
- Hypersensitivity to adhesive plasters
- Contraindications to 5-HT3 receptor antagonists
- Any other relevant medical history (at the discretion of the investigator)
- Concomitant Medical Condition
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 |
|---|---|---|
| Sancuso patchEligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy. | Drug | Sancuso patch |
| Kytril inj.+Kytril tab.Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Active Comparator arm: * Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1). * Kytril tab. 1mg: administered twice a day by orally at Day 2~4. | Drug | Kytril |
Primary outcome
The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
12 secondary outcomes
The percentage of patients achieving Complete Response (CR)
Time frame: overall (Day 1~4)
The percentage of patients achieving Complete Control (CC) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
The percentage of patients achieving Complete Control (CC)
Time frame: overall (Day 1~4)
severity of nausea
Time frame: overall (Day 1~4)
severity of vomiting
Time frame: overall (Day 1~4)
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen
Patient's satisfaction with anti-emetic therapy (Changes from Baseline to Day 5)
Time frame: from baseline to Day 5
The percentage of patients achieving Complete Response (CR)
Time frame: per day (Day 1, 2, 3, 4)
The percentage of patients achieving Complete Control (CC)
Time frame: per day (Day 1, 2, 3, 4)
severity of nausea
Time frame: per day (Day 1, 2, 3, 4)
severity of vomiting
Time frame: per day (Day 1, 2, 3, 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Derived from this study: PubMed 25465680Kim JE, Hong YS, Lee JL, Kim KP, Park SJ, Sym SJ, Shin DB, Lee J, Park YS, Ahn JS, Kim TW. A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Support Care Cancer. 2015 Jun;23(6):1769-77. doi: 10.1007/s00520-014-2507-6. Epub 2014 Dec 3.
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.
Jin Seok Ahn, MD, PhD principal investigator
Samsung Medical Center
Tae Won Kim, MD, PhD principal investigator
Asan Medical Center
Dong Bok Shin, MD, PhD principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sancuso patch and Kytril inj.+Kytril tab. in people with Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV), run by LG Life Sciences at 1 site in South Korea.
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 23 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: status not confirmed, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-Ae Eom, BS (82-2-6924-3157, yaeom@lgls.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients achieving Complete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen (time frame: from the first administration until 24h after the start of the last day's administration of the ME chemotherapy regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662687, which also lists 1 linked publication.
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 Aug 2012.