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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Nippon Biomedical Laboratories, Ltd.
• Treatments: Emetics; Granisetron

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.