Clinical trial NCT00787566: Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Official title: A Randomized, Single Administration, Double-blind, Parallel-group Phase 2 Dose Finding Study to Assess the Efficacy, Tolerability, and Safety of TRG (Intranasal Granisetron) in Patients With Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Highly emetogenic chemotherapy induced nausea and vomiting
Lead sponsor: Shin Nippon Biomedical Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Patients With Complete Control
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of Patients With Complete Response
timeFrame: 24 hours
measure: Percentage of Patients With Total Response
timeFrame: 24 hours
measure: Percentage of Patients With Major Control of Emesis
timeFrame: 24 hrs
measure: Percentage of Patients With Minor Control of Emesis
timeFrame: 24 hrs
measure: Percentage of Patients With Failure
timeFrame: 24 hrs
measure: Percentage of Patients Using Rescue Medications
timeFrame: 24 hours
measure: Time to First Emetic Episode
timeFrame: 24 hours
measure: Time to First Rescue Medication
timeFrame: 24 hours
measure: Time to Treatment Failure
timeFrame: 24 hours
measure: Number of Emetic Episodes
timeFrame: 24 hours
measure: Severity of Nausea Measured by a 4 Categorical Scale
timeFrame: 24 hours
measure: Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS
timeFrame: 24 hours
Other outcomes:
Locations:
city: The study is managed by Kendle International, in Wilmington
country: United States
facility: The study is conducted at 14 Centers, in 14 cities accross the United States
state: North Carolina
Study officials:
References: