phase 2 study of efficacy, tolerability, and safety of intranasal granisetron for chemo-induced nausea and vomiting

Conditions: Chemotherapy-Induced Nausea and Vomiting

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.


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.

Keywords: highly emetogenic chemotherapy induced nausea and vomiting