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)

NCT ID: NCT01662687

Last Updated: 2012-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-11-30

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)

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 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.

Kytril

Group Type: ACTIVE_COMPARATOR

Kytril inj.+Kytril tab.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• 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 Seok Ahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Tae Won Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Dong Bok Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yun-Ae Eom, BS

Role: CONTACT

Phone: 82-2-6924-3157

Email: yaeom@lgls.com

Facility Contacts

Jin Seok Ahn, MD, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25465680 (View on PubMed)

Other Identifiers

LG-SCSCL002

Identifier Type: -

Identifier Source: org_study_id