Trial Outcomes & Findings for Regimen for the Treatment of Cachexia in Subjects With NSCLC (NCT NCT00527319)
NCT ID: NCT00527319
Last Updated: 2013-01-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
4 weeks
Results posted on
2013-01-30
Participant Flow
First patient visit: March 23, 2007 Last patient visit: December 10, 2008
Participant milestones
| Measure |
Group A, Control Group
Supportive care only
|
Group B, Low Dose VT-122
VT-122 low dose Supportive care
|
Group C, High Dose VT-122
VT-122 high dose Supportive care
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
|
Overall Study
COMPLETED
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
6
|
Reasons for withdrawal
| Measure |
Group A, Control Group
Supportive care only
|
Group B, Low Dose VT-122
VT-122 low dose Supportive care
|
Group C, High Dose VT-122
VT-122 high dose Supportive care
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
3
|
1
|
|
Overall Study
Intercurrent Medical Illness
|
0
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Regimen for the Treatment of Cachexia in Subjects With NSCLC
Baseline characteristics by cohort
| Measure |
Group A, Control Group
n=12 Participants
Supportive care only
|
Group B, Low Dose VT-122
n=12 Participants
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
Group C, High Dose VT-122
n=13 Participants
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
54.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
37 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group A, Control Group
n=12 Participants
Supportive care only
|
Group B, Low Dose VT-122
n=12 Participants
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
Group C, High Dose VT-122
n=13 Participants
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
|---|---|---|---|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
<=0%
|
8 participants
|
6 participants
|
5 participants
|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
>0% to <5%
|
3 participants
|
3 participants
|
3 participants
|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
>=5%
|
1 participants
|
3 participants
|
4 participants
|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Data Missing
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group A, Control Group
n=12 Participants
Supportive care only
|
Group B, Low Dose VT-122
n=12 Participants
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
Group C, High Dose VT-122
n=13 Participants
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
|---|---|---|---|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
<=0%
|
4 participants
4.03
|
8 participants
3.56
|
7 participants
6.25
|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
>0% to <5%
|
3 participants
|
1 participants
|
2 participants
|
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
>=5%
|
5 participants
|
3 participants
|
4 participants
|
Adverse Events
Group A, Control Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B, Low Dose VT-122
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Group C, High Dose VT-122
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A, Control Group
n=12 participants at risk
Supportive care only
|
Group B, Low Dose VT-122
n=12 participants at risk
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
Group C, High Dose VT-122
n=13 participants at risk
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Cardiorespiratory Failure
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Disease Progression
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Death
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Group A, Control Group
n=12 participants at risk
Supportive care only
|
Group B, Low Dose VT-122
n=12 participants at risk
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
Group C, High Dose VT-122
n=13 participants at risk
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12
|
0.00%
0/12
|
15.4%
2/13 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/13
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Asthenia
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Chest Pain
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/13
|
|
General disorders
Crepitations
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
General disorders
Malaise
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Edema Peripheral
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/13
|
|
Infections and infestations
Infection
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
Tracheal Deviation
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Alanine Aminotransferase Increased (SGPT)
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
0.00%
0/13
|
|
Investigations
Aspartate Aminotransferase Increased (SGOT)
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Blood Creatinine Increased
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Breath Sounds Abnormal
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Investigations
Heart Rate Decreased
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Liver Palpable Subcostal
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Weight Decreased
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
30.8%
4/13 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Pallor
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
Additional Information
Dr. Richard Guarino
Oxford Pharmaceutical Resources, Inc.
Phone: 973-256-0600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60