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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by LG Life Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01662687
First received: August 8, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 276
Study Start Date: February 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 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 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.

  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. 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
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: NCT01662687

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

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01662687     History of Changes
Other Study ID Numbers: LG-SCSCL002
Study First Received: August 8, 2012
Last Updated: August 15, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014