Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Intranasal granisetron
Intervention description: 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
Intervention MeSH terms: Granisetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Highly emetogenic 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.