Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting

NCT ID: NCT00787566

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-05-31

Brief Summary

Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy.

Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

0.5 mg of TRG (intranasal granisetron)

0.5 mg dose, intranasal powder, single spray, administered once

Group Type: EXPERIMENTAL

Intranasal granisetron

Intervention Type: DRUG

0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

1.0 mg of TRG (intranasal granisetron)

1.0 mg dose, intranasal powder, songle spray, administered once

Group Type: EXPERIMENTAL

Intranasal granisetron

Intervention Type: DRUG

0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

2.0 mg of TRG (intranasal granisetron)

2.0 mg dose, intranasal powder, single spray, administered once

Group Type: EXPERIMENTAL

Intranasal granisetron

Intervention Type: DRUG

0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

Interventions

Intranasal granisetron

0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

Intervention Type: DRUG

Other Intervention Names

TRG

Eligibility Criteria

Inclusion Criteria

• Patients with histologically and/or cytologically confirmed cancer
• ECOG performance status of 0, 1, or 2
• Patients with life expectancy of at least 3 months
• Patients who are chemotherapy naïve
• Patients who will be receiving the first cycle of a highly emetogenic regimen according to the MASCC criteria or the Hesketh criteria
• Patients with adequate metabolic or hematologic values for chemotherapy
• Patients with intact nasal mucosa
• Non child-bearing potential patients
• Patients able to read and write at a competent level, and capable of giving legal consent
• Patients who have provided written informed consent

Exclusion Criteria

• Patients who do not receive a chemotherapy regimen which is a highly emetogenic chemotherapy regimen according to the MASCC or the Hesketh criteria
• Patients with nasal cancers, pharyngeal cancers, maxillary sinus cancers, or ethmoid sinus cancers
• Patients with nasal ulcers, septal perforation, or other nasal conditions that may interfere with IN administration
• Patients with any episode of retching, vomiting, or uncontrolled nausea within 48 hours before dosing with TRG and/or administration of chemotherapy
• Patients who have received radiation therapy in the 14 days before dosing with TRG, or for whom radiation therapy is scheduled during the 7 days after a TRG dose
• Patients who have received any investigational product within 30 days prior to study entry
• Patients who have received any drug or who were scheduled to receive any drug with antiemetic efficacy within 24 hours of the start of treatment
• Patients who have an allergy or hypersensitivity to granisetron or other selective 5hydroxytryptamine3(5-HT3) receptor antagonists
• Patients with ECOG performance status of 3 or 4
• Patients who have or have a history of brain tumors, head cancers, or neck cancers
• Patients who have a psychological problem that, in the Investigator's opinion, is severe enough to interfere with study eligibility or with interpretation of study results
• Patients who are pregnant (urine test) or breastfeeding
• Patients who have received prior cytotoxic chemotherapy given for the treatment of cancer
• Patients scheduled to receive multiple day chemotherapy
• Patients with clinically relevant abnormal laboratory values at the discretion of the Investigator
• Patients with clinically relevant hepatic, renal, infectious, neurological, or psychiatric disorders, or any other major systemic illness at the discretion of the Investigator
• Patients with any prevalence or cause of nausea and vomiting other than chemotherapy
• Patients using systemic steroids for any indication, or patients using steroids other than dexamethasone for prevention of chemotherapy-induced nausea and vomiting, or patients using dexamethasone for chemotherapy-induced nausea and vomiting at doses other than recommended in the MASCC antiemetic guidelines
• Patients with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history
• Patients with a history of drug and/or alcohol abuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Nippon Biomedical Laboratories, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Aviana Consulting, LLC

Locations

The study is conducted at 14 Centers, in 14 cities accross the United States

The Study Is Managed by Kendle International, in Wilmington, North Carolina, United States

Countries

United States

Other Identifiers

TRG-002

Identifier Type: -

Identifier Source: org_study_id