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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01659775
First received: July 27, 2012
Last updated: July 23, 2013
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)
Drug: Sancuso patch
Drug: Zofran inj.+Zofran tab.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

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 [ Time Frame: from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of patients achieving Complete Response (CR) [ Time Frame: overall (Day 1~5) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The percentage of patients achieving Compete Control (CC) [ Time Frame: overall (Day 1~5) ] [ Designated as safety issue: No ]
  • severity of nausea [ Time Frame: overall (Day 1~5) ] [ Designated as safety issue: No ]
  • severity of vomiting [ Time Frame: overall (Day 1~5) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patient's satisfaction with anti-emetic therapy [ Time Frame: overall (Day 1~5) ] [ Designated as safety issue: No ]
    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) [ Time Frame: per day (Day1, 2, 3, 4, 5) ] [ Designated as safety issue: No ]
  • The percentage of patients achieving Compete Control (CC) [ Time Frame: per day (Day 1, 2, 3, 4, 5) ] [ Designated as safety issue: No ]
  • severity of nausea [ Time Frame: per day (Day 1, 2, 3, 4, 5) ] [ Designated as safety issue: No ]
  • severity of vomiting [ Time Frame: per day (Day 1, 2, 3, 4, 5) ] [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sancuso patch Drug: Sancuso patch

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.

Active Comparator: Zofran Drug: Zofran inj.+Zofran tab.

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.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659775

Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Jin-Hyoung Kang, MD,PhD Seoul St'. Mary's Hospital
Principal Investigator: Hoon-Kyo Kim, MD,PhD St. Vincent’s Hospital.
Principal Investigator: Suk-Young Park, MD,PhD The Catholic University of Korea
Principal Investigator: Jong-Youl Jin, MD,PhD The Catholic University of Korea
Principal Investigator: In-Sook Woo, MD,PhD The Catholic University of Korea
Principal Investigator: Yoon-Ho Ko, MD,PhD Uijeongbu St. Mary's Hospital
Principal Investigator: Der-Sheng Sun, MD,PhD Cheongju St. Mary's Hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01659775     History of Changes
Other Study ID Numbers: LG-SCSCL001
Study First Received: July 27, 2012
Last Updated: July 23, 2013
Health Authority: South Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014