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)

NCT01659775 | Completed Phase 4

• 1 other identifier: LG-SCSCL001
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)

Outcome Measures

Primary Outcomes (1)

• 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

  from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen

Secondary Outcomes (12)

• The percentage of patients achieving Complete Response (CR)

  overall (Day 1~5)

• 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

  from the first administration until 24h after the start of the last day's administration of the chemotherapy regimen

• The percentage of patients achieving Compete Control (CC)

  overall (Day 1~5)

• severity of nausea

  overall (Day 1~5)

• severity of vomiting

  overall (Day 1~5)

Study Arms (2)

Sancuso patch

EXPERIMENTAL

Drug: Sancuso patch

Zofran

ACTIVE COMPARATOR

Drug: Zofran inj.+Zofran tab.

Interventions

Sancuso patch DRUG

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.

Sancuso patch

Zofran inj.+Zofran tab. DRUG

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.

Zofran

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 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 of study entry or planned during the study
• 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)

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  Daejeon St. Mary's hospital

  PRINCIPAL INVESTIGATOR

• Jong-Youl Jin, MD,PhD

  Bucheon St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• In-Sook Woo, MD,PhD

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Yoon-Ho Ko, MD,PhD

  Uijeongbu St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Der-Sheng Sun, MD,PhD

  Cheongju St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 25, 2013

Record last verified: 2012-01

Locations

KR (1)