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

This study has been completed.
Sponsor:
Information provided by:
Shin Nippon Biomedical Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00787566
First received: November 5, 2008
Last updated: July 5, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
 Drug: Intranasal granisetron
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shin Nippon Biomedical Laboratories, Ltd.:

Primary Outcome Measures:
  • Percentage of Patients With Complete Control [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.


Secondary Outcome Measures:
  • Percentage of Patients With Complete Response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Complete Response is defined as no emetic episodes and no use of rescue medications

  • Percentage of Patients With Total Response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications

  • Percentage of Patients With Major Control of Emesis [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Major Control of emesis = 2 emetic episodes

  • Percentage of Patients With Minor Control of Emesis [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Minor Control of emesis: 3-5 emetic episodes

  • Percentage of Patients With Failure [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Failure: > 5 emetic episodes

  • Percentage of Patients Using Rescue Medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to First Emetic Episode [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to First Rescue Medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first

  • Number of Emetic Episodes [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Severity of Nausea Measured by a 4 Categorical Scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)

  • Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied


Enrollment: 68
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg of TRG (intranasal granisetron)
0.5 mg dose, intranasal powder, single spray, administered once
 Drug: Intranasal granisetron
0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
Other Name: TRG
Experimental: 1.0 mg of TRG (intranasal granisetron)
1.0 mg dose, intranasal powder, songle spray, administered once
 Drug: Intranasal granisetron
0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
Other Name: TRG
Experimental: 2.0 mg of TRG (intranasal granisetron)
2.0 mg dose, intranasal powder, single spray, administered once
 Drug: Intranasal granisetron
0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen
Other Name: TRG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787566

Locations
United States, North Carolina
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
Sponsors and Collaborators
Shin Nippon Biomedical Laboratories, Ltd.
  More Information

No publications provided

Responsible Party: Vanaja Ragavan, MD, Aviana Consulting, LLC
ClinicalTrials.gov Identifier: NCT00787566     History of Changes
Other Study ID Numbers: TRG-002
Study First Received: November 5, 2008
Results First Received: May 24, 2011
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Shin Nippon Biomedical Laboratories, Ltd.:
Highly emetogenic chemotherapy induced nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Granisetron
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antiemetics
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013