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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg of TRG (intranasal granisetron) | Experimental | 0.5 mg dose, intranasal powder, single spray, administered once |
|
| 1.0 mg of TRG (intranasal granisetron) | Experimental | 1.0 mg dose, intranasal powder, songle spray, administered once |
|
| 2.0 mg of TRG (intranasal granisetron) | Experimental | 2.0 mg dose, intranasal powder, single spray, administered once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Response | Complete Response is defined as no emetic episodes and no use of rescue medications | 24 hours |
| Percentage of Patients With Total Response | Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 mg of TRG (Intranasal Granisetron) | 0.5 mg dose, intranasal powder, single spray, administered once |
| FG001 | 1.0 mg of TRG (Intranasal Granisetron) | 1.0 mg dose, intranasal powder, single spray, administered once |
| FG002 | 2.0 mg of TRG (Intranasal Granisetron) | 2.0 mg dose, intranasal powder, single spray, administered once |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 mg of TRG (Intranasal Granisetron) | 0.5 mg dose, intranasal powder, single spray, administered once |
| BG001 | 1.0 mg of TRG (Intranasal Granisetron) | 1.0 mg dose, intranasal powder, single spray, administered once |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population | Posted | Number | Percentage | 24 hours |
|
Dosing of study drug through safety follow-up period (maximum 38 days)
Telephone questioning 2-24 hours after start of chemotherapy; 8 day patient diary
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5 mg of TRG (Intranasal Granisetron) | 0.5 mg dose, intranasal powder, single spray, administered once |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment | Not related to study mediation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanaja V. Ragavan, M.D. | Aviana Consulting, LLC | 610-795-7403 | vvragavan@comcast.net |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 24 hours |
| Percentage of Patients With Major Control of Emesis | Major Control of emesis = 2 emetic episodes | 24 hrs |
| Percentage of Patients With Minor Control of Emesis | Minor Control of emesis: 3-5 emetic episodes | 24 hrs |
| Percentage of Patients With Failure | Failure: > 5 emetic episodes | 24 hrs |
| Percentage of Patients Using Rescue Medications | 24 hours |
| Time to First Emetic Episode | 24 hours |
| Time to First Rescue Medication | 24 hours |
| Time to Treatment Failure | Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first | 24 hours |
| Number of Emetic Episodes | 24 hours |
| Severity of Nausea Measured by a 4 Categorical Scale | 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) | 24 hours |
| Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS | VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied | 24 hours |
| BG002 | 2.0 mg of TRG (Intranasal Granisetron) | 2.0 mg dose, intranasal powder, single spray, administered once |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 2.0 mg of TRG (Intranasal Granisetron) |
2.0 mg dose, intranasal powder, single spray, administered once |
|
|
| Secondary | Percentage of Patients With Complete Response | Complete Response is defined as no emetic episodes and no use of rescue medications | Not Posted | 24 hours |
| Secondary | Percentage of Patients With Total Response | Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications | Not Posted | 24 hours |
| Secondary | Percentage of Patients With Major Control of Emesis | Major Control of emesis = 2 emetic episodes | Not Posted | 24 hrs |
| Secondary | Percentage of Patients With Minor Control of Emesis | Minor Control of emesis: 3-5 emetic episodes | Not Posted | 24 hrs |
| Secondary | Percentage of Patients With Failure | Failure: > 5 emetic episodes | Not Posted | 24 hrs |
| Secondary | Percentage of Patients Using Rescue Medications | Not Posted | 24 hours |
| Secondary | Time to First Emetic Episode | Not Posted | 24 hours |
| Secondary | Time to First Rescue Medication | Not Posted | 24 hours |
| Secondary | Time to Treatment Failure | Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first | Not Posted | 24 hours |
| Secondary | Number of Emetic Episodes | Not Posted | 24 hours |
| Secondary | Severity of Nausea Measured by a 4 Categorical Scale | 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) | Not Posted | 24 hours |
| Secondary | Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS | VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied | Not Posted | 24 hours |
| 2 |
| 21 |
| 16 |
| 21 |
| EG001 | 1.0 mg of TRG (Intranasal Granisetron) | 1.0 mg dose, intranasal powder, single spray, administered once | 1 | 25 | 16 | 25 |
| EG002 | 2.0 mg of TRG (Intranasal Granisetron) | 2.0 mg dose, intranasal powder, single spray, administered once | 1 | 22 | 15 | 22 |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
|
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
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| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
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| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment | Not related to study medication |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Weight decrease | Investigations | MedDRA 11.0 | Systematic Assessment |
|
SNBL and investigators agreed that SNBL would retain the exclusive right to disseminate data arising from the study through either publication or presentation, including study results, and that SNBL would retain exclusive editorial rights over manuscripts or presentations.