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)

Study Description

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Brief 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.

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 Design

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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

Arms and Interventions

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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: 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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. The percentage of patients achieving Complete Response (CR) [ Time Frame: overall (Day 1~4) ]
2. 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 ]
3. The percentage of patients achieving Complete Control (CC) [ Time Frame: overall (Day 1~4) ]
4. severity of nausea [ Time Frame: overall (Day 1~4) ]
5. severity of vomiting [ Time Frame: overall (Day 1~4) ]
6. 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 ]
7. 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 ]
8. 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.
9. The percentage of patients achieving Complete Response (CR) [ Time Frame: per day (Day 1, 2, 3, 4) ]
10. The percentage of patients achieving Complete Control (CC) [ Time Frame: per day (Day 1, 2, 3, 4) ]
11. severity of nausea [ Time Frame: per day (Day 1, 2, 3, 4) ]
12. severity of vomiting [ Time Frame: per day (Day 1, 2, 3, 4) ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Male or female aged over 20 yrs
2. Histologically and/or cytologically proven cancer patients
3. Eastern Cooperative Oncology Group performance status 0, 1, 2
4. A cycle of moderately emetogenic chemotherapy(NCCN Guidelines)
5. Life expectancy of ≥ 3 months
6. 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
7. 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 heart, 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 prior to the study entry or planned during the study
2. 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)
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 clinical trial drug < 30 days before the study 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 during chemotherapy duration
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

Contacts and Locations

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Contacts

Contact: Yun-Ae Eom, BS	82-2-6924-3157	yaeom@lgls.com

Locations

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

Sponsors and Collaborators

LG Life Sciences

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	LG Life Sciences
ClinicalTrials.gov Identifier:	NCT01662687 History of Changes
Other Study ID Numbers:	LG-SCSCL002
First Posted:	August 10, 2012
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