Status:
COMPLETED
Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Lead Sponsor:
Shin Nippon Biomedical Laboratories, Ltd.
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-induc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00787566
Start Date
October 1 2008
End Date
May 1 2009
Last Update
July 12 2011
Active Locations (1)
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1
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, 28405