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

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.