Trial Outcomes & Findings for Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting (NCT NCT00787566)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

24 hours

Results posted on

2011-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	0.5 mg of TRG (Intranasal Granisetron) 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) 2.0 mg dose, intranasal powder, single spray, administered once
Overall Study STARTED	21	25	22
Overall Study COMPLETED	21	24	22
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	0.5 mg of TRG (Intranasal Granisetron) 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) 2.0 mg dose, intranasal powder, single spray, administered once
Overall Study AE related to chemotherapy	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.5 mg of TRG (Intranasal Granisetron) n=21 Participants 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) n=25 Participants 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) n=22 Participants 2.0 mg dose, intranasal powder, single spray, administered once	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Age Continuous	55.4 years STANDARD_DEVIATION 15.9 • n=5 Participants	60.0 years STANDARD_DEVIATION 10.2 • n=7 Participants	61.0 years STANDARD_DEVIATION 12.0 • n=5 Participants	58.9 years STANDARD_DEVIATION 12.8 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	25 participants n=7 Participants	22 participants n=5 Participants	68 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	0.5 mg of TRG (Intranasal Granisetron) n=21 Participants 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) n=25 Participants 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) n=22 Participants 2.0 mg dose, intranasal powder, single spray, administered once
Percentage of Patients With Complete Control	71.4 Percentage	76.0 Percentage	90.9 Percentage

SECONDARY outcome

Timeframe: 24 hours

Complete Response is defined as no emetic episodes and no use of rescue medications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs

Major Control of emesis = 2 emetic episodes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs

Minor Control of emesis: 3-5 emetic episodes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs

Failure: \> 5 emetic episodes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied

Outcome measures

Outcome data not reported

Adverse Events

0.5 mg of TRG (Intranasal Granisetron)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

1.0 mg of TRG (Intranasal Granisetron)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

2.0 mg of TRG (Intranasal Granisetron)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.5 mg of TRG (Intranasal Granisetron) n=21 participants at risk 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) n=25 participants at risk 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) n=22 participants at risk 2.0 mg dose, intranasal powder, single spray, administered once
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Vascular disorders Hypotension	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/21 • 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	4.0% 1/25 • Number of events 1 • 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	0.00% 0/22 • 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
Blood and lymphatic system disorders Pancytopenia	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Blood and lymphatic system disorders Neutropenia	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	0.00% 0/22 • 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
Cardiac disorders Tachycardia	0.00% 0/21 • 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	0.00% 0/25 • 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	4.5% 1/22 • Number of events 1 • 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

Other adverse events

Additional Information

Vanaja V. Ragavan, M.D.

Aviana Consulting, LLC

Phone: 610-795-7403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	0.5 mg of TRG (Intranasal Granisetron) n=21 participants at risk 0.5 mg dose, intranasal powder, single spray, administered once	1.0 mg of TRG (Intranasal Granisetron) n=25 participants at risk 1.0 mg dose, intranasal powder, single spray, administered once	2.0 mg of TRG (Intranasal Granisetron) n=22 participants at risk 2.0 mg dose, intranasal powder, single spray, administered once
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • 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	16.0% 4/25 • Number of events 4 • 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	0.00% 0/22 • 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
Psychiatric disorders Anxiety	4.8% 1/21 • Number of events 1 • 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	8.0% 2/25 • Number of events 2 • 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	0.00% 0/22 • 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
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • Number of events 1 • 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	8.0% 2/25 • Number of events 2 • 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	0.00% 0/22 • 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
Gastrointestinal disorders Constipation	14.3% 3/21 • Number of events 3 • 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	0.00% 0/25 • 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	4.5% 1/22 • Number of events 1 • 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
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • 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	4.0% 1/25 • Number of events 1 • 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	9.1% 2/22 • Number of events 2 • 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
Gastrointestinal disorders Diarrhoea	19.0% 4/21 • Number of events 4 • 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	12.0% 3/25 • Number of events 3 • 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	0.00% 0/22 • 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
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.5% 2/21 • Number of events 2 • 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	0.00% 0/25 • 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	9.1% 2/22 • Number of events 2 • 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
Nervous system disorders Dizziness	9.5% 2/21 • Number of events 2 • 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	8.0% 2/25 • Number of events 2 • 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	4.5% 1/22 • Number of events 1 • 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
Gastrointestinal disorders Dyspepsia	0.00% 0/21 • 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	12.0% 3/25 • Number of events 3 • 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	9.1% 2/22 • Number of events 2 • 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
General disorders Fatigue	38.1% 8/21 • Number of events 8 • 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	24.0% 6/25 • Number of events 6 • 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	22.7% 5/22 • Number of events 5 • 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
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/21 • 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	8.0% 2/25 • Number of events 2 • 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	0.00% 0/22 • 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
Nervous system disorders Headache	19.0% 4/21 • Number of events 4 • 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	20.0% 5/25 • Number of events 5 • 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	18.2% 4/22 • Number of events 4 • 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
Vascular disorders Hypotension	4.8% 1/21 • Number of events 1 • 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	0.00% 0/25 • 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	9.1% 2/22 • Number of events 2 • 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
Gastrointestinal disorders Nausea	33.3% 7/21 • Number of events 7 • 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	16.0% 4/25 • Number of events 4 • 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	22.7% 5/22 • Number of events 5 • 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
Blood and lymphatic system disorders Neutropenia	9.5% 2/21 • Number of events 2 • 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	20.0% 5/25 • Number of events 5 • 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	9.1% 2/22 • Number of events 2 • 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
Blood and lymphatic system disorders Thrombocytopenia	9.5% 2/21 • Number of events 2 • 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	4.0% 1/25 • Number of events 1 • 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	0.00% 0/22 • 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
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1 • 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	8.0% 2/25 • Number of events 2 • 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	4.5% 1/22 • Number of events 1 • 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
Investigations Weight decrease	9.5% 2/21 • Number of events 2 • 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	0.00% 0/25 • 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	9.1% 2/22 • Number of events 2 • 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