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)

NCT ID: NCT01659775

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-11-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sancuso patch

Group Type: EXPERIMENTAL

Sancuso patch

Intervention Type: 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.

Zofran

Group Type: ACTIVE_COMPARATOR

Zofran inj.+Zofran tab.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Hyoung Kang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St'. Mary's Hospital

Hoon-Kyo Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital

Suk-Young Park, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Daejeon St. Mary's hospital

Jong-Youl Jin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Bucheon St. Mary's Hospital

In-Sook Woo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Yeouido St. Mary's Hospital

Yoon-Ho Ko, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Uijeongbu St. Mary's Hospital

Der-Sheng Sun, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cheongju St. Mary's Hospital

Locations

Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-SCSCL001

Identifier Type: -

Identifier Source: org_study_id