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)

NCT01662687 | Unknown Phase 4

• 1 other identifier: LG-SCSCL002
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (12)

• The percentage of patients achieving Complete Response (CR)

  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

  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)

  overall (Day 1~4)

• severity of nausea

  overall (Day 1~4)

• severity of vomiting

  overall (Day 1~4)

Study Arms (2)

Sancuso patch

EXPERIMENTAL

Drug: Sancuso patch

Kytril

ACTIVE COMPARATOR

Drug: Kytril inj.+Kytril tab.

Interventions

Sancuso patch DRUG

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.

Sancuso patch

Kytril inj.+Kytril tab. DRUG

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.

Kytril

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
• 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

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 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)

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 25465680 DERIVED

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Ae Eom, BS

CONTACT

82-2-6924-3157; yaeom@lgls.com

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: August 8, 2012
• First Posted: August 10, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

KR (1)