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
Overview
- Phase
- Phase 4
- Intervention
- Sancuso patch
- Conditions
- Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
- Sponsor
- LG Life Sciences
- Enrollment
- 389
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
Sancuso patch
Intervention: Sancuso patch
Zofran
Intervention: Zofran inj.+Zofran tab.
Outcomes
Primary Outcomes
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 Outcomes
- The percentage of patients achieving Compete Control (CC)(per day (Day 1, 2, 3, 4, 5))
- The percentage of patients achieving Complete Response (CR)(per day (Day1, 2, 3, 4, 5))
- 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(from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen)
- severity of nausea(per day (Day 1, 2, 3, 4, 5))
- severity of vomiting(per day (Day 1, 2, 3, 4, 5))
- Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen(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(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(overall (Day 1~5))