Clinical trial NCT01659775: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 389
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged over 20 yrs
2. Eastern Cooperative Oncology Group performance status 0, 1, 2
3. Life expectancy of ≥ 3 months
4. 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)
5. Patients who signed the informed consent form

Exclusion Criteria:

A. Previous History

1. Hypersensitivity to adhesive plasters
2. Contraindications to 5-HT3 receptor antagonists
3. Any other relevant medical history (at the discretion of the investigator)

B. Concomitant Medical Condition

1. Current alcohol, drug or medication abuse
2. Currently pregnant or breast feeding women, including planning pregnancy
3. Clinically relevant abnormal laboratory values (at the discretion of the investigator)
4. Clinically relevant hepatic, renal, infectious, neurological or psychiatric disorders, or any other major systemic illness (at the discretion of the investigator)
5. Any cause for nausea and vomiting other than CINV
6. Any episode of retching, vomiting or uncontrolled nausea in the 72 h period prior to the chemotherapy administration
7. Clinically relevant abnormal ECG parameters at the discretion of the investigator

C. Concomitant Therapy/Medication

1. Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study
2. 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)
3. Patients using selective serotonin reuptake inhibitor (SSRI) antidepressants (unless a stable dose for the duration of the study)
4. Receipt of a narcotic analgesics (acceptable at the discretion of the investigator)
5. Receipt of any other investigational drug \< 30 days before the study start or during the study
6. 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
7. 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

1. 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
2. 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

Primary outcomes:
measure: 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
timeFrame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
Secondary outcomes:
measure: The percentage of patients achieving Complete Response (CR)
timeFrame: overall (Day 1~5)
measure: 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
timeFrame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
measure: The percentage of patients achieving Compete Control (CC)
timeFrame: overall (Day 1~5)
measure: severity of nausea
timeFrame: overall (Day 1~5)
measure: severity of vomiting
timeFrame: overall (Day 1~5)
measure: Frequency of nausea from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
timeFrame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
measure: Frequency of vomiting from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
timeFrame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen
measure: Patient's satisfaction with anti-emetic therapy
timeFrame: overall (Day 1~5)
measure: The percentage of patients achieving Complete Response (CR)
timeFrame: per day (Day1, 2, 3, 4, 5)
measure: The percentage of patients achieving Compete Control (CC)
timeFrame: per day (Day 1, 2, 3, 4, 5)
measure: severity of nausea
timeFrame: per day (Day 1, 2, 3, 4, 5)
measure: severity of vomiting
timeFrame: per day (Day 1, 2, 3, 4, 5)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St'. Mary's Hospital
name: Jin-Hyoung Kang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital
name: Hoon-Kyo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daejeon St. Mary's hospital
name: Suk-Young Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon St. Mary's Hospital
name: Jong-Youl Jin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeouido St. Mary's Hospital
name: In-Sook Woo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uijeongbu St. Mary's Hospital
name: Yoon-Ho Ko, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheongju St. Mary's Hospital
name: Der-Sheng Sun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: