Back to resultsPhase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)
Primary Purpose
Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sancuso patch
Zofran inj.+Zofran tab.
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
Eligibility Criteria
Inclusion Criteria:
- Male or female aged over 20 yrs
- Eastern Cooperative Oncology Group performance status 0, 1, 2
- Life expectancy of ≥ 3 months
- Assigned to receive a cycle of high emetic (HE) chemotherapy regimen including the daily administration of a cytotoxic regimen with the emetogenic potential of level 5 (Hesketh Classification)
- Patients who signed the informed consent form
Exclusion Criteria:
A. Previous History
- Hypersensitivity to adhesive plasters
- Contraindications to 5-HT3 receptor antagonists
- Any other relevant medical history (at the discretion of the investigator)
B. Concomitant Medical Condition
- Current alcohol, drug or medication abuse
- Currently pregnant or breast feeding women, including planning pregnancy
- Clinically relevant abnormal laboratory values (at the discretion of the investigator)
- Clinically relevant 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
C. Concomitant Therapy/Medication
- Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
- Intake of medication to control the symptoms of a brain tumour, 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 investigational drug < 30 days before the study start 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 after patch removal
- Drugs known to increase the QTc interval (unless a stable dose for the duration of the study at the discretion of the investigator)
D. 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
Sites / Locations
- Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sancuso patch
Zofran
Arm Description
Outcomes
Primary Outcome Measures
The percentage of patients achieving Compete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Secondary Outcome Measures
The percentage of patients achieving Complete Response (CR)
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 chemotherapy regimen
The percentage of patients achieving Compete Control (CC)
severity of nausea
severity of vomiting
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Patient's satisfaction with anti-emetic therapy
The overall response to anti-emetic therapy was assessed and recorded by patients at Visit 8. 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.
The percentage of patients achieving Complete Response (CR)
The percentage of patients achieving Compete Control (CC)
severity of nausea
severity of vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659775
Brief Title
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)
Official Title
A Multicenter, Randomized, Open-label, Paralleled-group, Active-controlled, Phase IV Study to Evaluate the Efficacy and Safety of Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic (HE) Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, randomized, open-label, paralleled-group, active-controlled study.
The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) efficacy compared with the ondansetron efficacy with regard to Complete Response (CR) of Chemotherapy Induced Nausea and Vomiting (CINV).
Patients scheduled to receive the one cycle of a HE chemotherapy regimen administered for 1-5 days will attend a Screening Visit 2 to 14 days before start of HE chemotherapy. Eligible patients will be randomized to 1 of 2 treatment groups at the Randomization Visit (1 to 2 days prior to HE chemotherapy).
Sancuso patch
Zofran inj. + Zofran tab.
The patch will be applied 2days (48-24h) prior to first daily dose of the highly emetogenic chemotherapy regimen and remain in place for 5 days after start of chemotherapy. The patient will be assessed daily until 5days after first chemotherapy administration. Adverse Events (AEs) will be collected until 2 days after the final dose of IP. Non-serious AEs will be followed-up until 2 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sancuso patch
Arm Type
Experimental
Arm Title
Zofran
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sancuso patch
Intervention Description
Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days.
Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24hours) prior to start of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Zofran inj.+Zofran tab.
Intervention Description
Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days.
Active Comparator arm: administered intravenously (24mg or 32mg) on Day 1 of chemotherapy and orally (8mg bid) on Day 2-5.
Primary Outcome Measure Information:
Title
The percentage of patients achieving Compete Response (CR) without rescue therapy from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time Frame
from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Secondary Outcome Measure Information:
Title
The percentage of patients achieving Complete Response (CR)
Time Frame
overall (Day 1~5)
Title
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 chemotherapy regimen
Time Frame
from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Title
The percentage of patients achieving Compete Control (CC)
Time Frame
overall (Day 1~5)
Title
severity of nausea
Time Frame
overall (Day 1~5)
Title
severity of vomiting
Time Frame
overall (Day 1~5)
Title
Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time Frame
from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Title
Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Time Frame
from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Title
Patient's satisfaction with anti-emetic therapy
Description
The overall response to anti-emetic therapy was assessed and recorded by patients at Visit 8. 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.
Time Frame
overall (Day 1~5)
Title
The percentage of patients achieving Complete Response (CR)
Time Frame
per day (Day1, 2, 3, 4, 5)
Title
The percentage of patients achieving Compete Control (CC)
Time Frame
per day (Day 1, 2, 3, 4, 5)
Title
severity of nausea
Time Frame
per day (Day 1, 2, 3, 4, 5)
Title
severity of vomiting
Time Frame
per day (Day 1, 2, 3, 4, 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged over 20 yrs
Eastern Cooperative Oncology Group performance status 0, 1, 2
Life expectancy of ≥ 3 months
Assigned to receive a cycle of high emetic (HE) chemotherapy regimen including the daily administration of a cytotoxic regimen with the emetogenic potential of level 5 (Hesketh Classification)
Patients who signed the informed consent form
Exclusion Criteria:
A. Previous History
Hypersensitivity to adhesive plasters
Contraindications to 5-HT3 receptor antagonists
Any other relevant medical history (at the discretion of the investigator)
B. Concomitant Medical Condition
Current alcohol, drug or medication abuse
Currently pregnant or breast feeding women, including planning pregnancy
Clinically relevant abnormal laboratory values (at the discretion of the investigator)
Clinically relevant 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
C. Concomitant Therapy/Medication
Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
Intake of medication to control the symptoms of a brain tumour, 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 investigational drug < 30 days before the study start 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 after patch removal
Drugs known to increase the QTc interval (unless a stable dose for the duration of the study at the discretion of the investigator)
D. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Hyoung Kang, MD,PhD
Organizational Affiliation
Seoul St'. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoon-Kyo Kim, MD,PhD
Organizational Affiliation
St Vincent's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suk-Young Park, MD,PhD
Organizational Affiliation
Daejeon St. Mary's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-Youl Jin, MD,PhD
Organizational Affiliation
Bucheon St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
In-Sook Woo, MD,PhD
Organizational Affiliation
Yeouido St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoon-Ho Ko, MD,PhD
Organizational Affiliation
Uijeongbu St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Der-Sheng Sun, MD,PhD
Organizational Affiliation
Cheongju St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)
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