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)
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ClinicalTrials.gov Identifier: NCT01662687 |
Recruitment Status
: Unknown
Verified August 2012 by LG Life Sciences.
Recruitment status was: Recruiting
First Posted
: August 10, 2012
Last Update Posted
: August 17, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV) | Drug: Sancuso patch Drug: Kytril inj.+Kytril tab. | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 276 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | October 2012 |
Estimated Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Sancuso patch |
Drug: Sancuso patch
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. |
Active Comparator: Kytril |
Drug: Kytril inj.+Kytril tab.
Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days. Active Comparator arm:
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- 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 ]
- 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 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.
- 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) ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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 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)
C. 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)
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662687
Contact: Yun-Ae Eom, BS | 82-2-6924-3157 | yaeom@lgls.com |
Korea, Republic of | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Jin Seok Ahn, MD, PhD 82-2-3410-3453 ajis@skku.edu | |
Principal Investigator: Jin Seok Ahn, MD, PhD |
Principal Investigator: | Jin Seok Ahn, MD, PhD | Samsung Medical Center | |
Principal Investigator: | Tae Won Kim, MD, PhD | Asan Medical Center | |
Principal Investigator: | Dong Bok Shin, MD, PhD | Gachon University Gil Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | LG Life Sciences |
ClinicalTrials.gov Identifier: | NCT01662687 History of Changes |
Other Study ID Numbers: |
LG-SCSCL002 |
First Posted: | August 10, 2012 Key Record Dates |
Last Update Posted: | August 17, 2012 |
Last Verified: | August 2012 |
Additional relevant MeSH terms:
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Emetics Granisetron Physiological Effects of Drugs Autonomic Agents |
Peripheral Nervous System Agents Gastrointestinal Agents Antiemetics Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |