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

NCT00787566 | Completed Phase 2 Results

• 1 other identifier: TRG-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Keywords

Highly emetogenic chemotherapy induced nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Complete Control

  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.

  24 hours

Secondary Outcomes (12)

• Percentage of Patients With Complete Response

  24 hours

• Percentage of Patients With Total Response

  24 hours

• Percentage of Patients With Major Control of Emesis

  24 hrs

• Percentage of Patients With Minor Control of Emesis

  24 hrs

• Percentage of Patients With Failure

  24 hrs

Study Arms (3)

0.5 mg of TRG (intranasal granisetron)

EXPERIMENTAL

0.5 mg dose, intranasal powder, single spray, administered once

Drug: Intranasal granisetron

1.0 mg of TRG (intranasal granisetron)

EXPERIMENTAL

1.0 mg dose, intranasal powder, songle spray, administered once

Drug: Intranasal granisetron

2.0 mg of TRG (intranasal granisetron)

EXPERIMENTAL

2.0 mg dose, intranasal powder, single spray, administered once

Drug: Intranasal granisetron

Interventions

Intranasal granisetron DRUG

0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

Also known as: TRG

0.5 mg of TRG (intranasal granisetron); 1.0 mg of TRG (intranasal granisetron); 2.0 mg of TRG (intranasal granisetron)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Nippon Biomedical Laboratories, Ltd.: lead

Study Sites (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, 28405, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vanaja V. Ragavan, M.D.
• Organization: Aviana Consulting, LLC

vvragavan@comcast.net

610-795-7403

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 7, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 12, 2011
• Results First Posted: June 21, 2011

Record last verified: 2011-07

Locations

US (1)