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Regimen for the Treatment of Cachexia in Subjects With NSCLC (VT-122)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527319
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Vicus Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Cachexia
Interventions Drug: VT-122 low dose
Drug: VT-122 high dose
Enrollment 37
Recruitment Details First patient visit: March 23, 2007 Last patient visit: December 10, 2008
Pre-assignment Details  
Arm/Group Title Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Hide Arm/Group Description Supportive care only VT-122 low dose Supportive care VT-122 high dose Supportive care
Period Title: Overall Study
Started 12 12 13
Completed 6 8 7
Not Completed 6 4 6
Reason Not Completed
Withdrawal by Subject             5             0             1
Lost to Follow-up             1             0             0
Death             0             3             1
Intercurrent Medical Illness             0             1             3
Adverse Event             0             0             1
Arm/Group Title Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122 Total
Hide Arm/Group Description Supportive care only VT-122 (dose of etodolac: 400 mg/day) + supportive care VT-122 (dose of etodolac: 800 mg/day) + supportive care Total of all reporting groups
Overall Number of Baseline Participants 12 12 13 37
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 13 participants 37 participants
54.1  (12.0) 55.1  (7.6) 57.6  (10.4) 55.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 13 participants 37 participants
Female
3
  25.0%
6
  50.0%
3
  23.1%
12
  32.4%
Male
9
  75.0%
6
  50.0%
10
  76.9%
25
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 12 participants 12 participants 13 participants 37 participants
12 12 13 37
1.Primary Outcome
Title Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Hide Arm/Group Description:
Supportive care only
VT-122 (dose of etodolac: 400 mg/day) + supportive care
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Overall Number of Participants Analyzed 12 12 13
Measure Type: Number
Unit of Measure: participants
<=0% 8 6 5
>0% to <5% 3 3 3
>=5% 1 3 4
Data Missing 0 0 1
2.Primary Outcome
Title Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Hide Arm/Group Description:
Supportive care only
VT-122 (dose of etodolac: 400 mg/day) + supportive care
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Overall Number of Participants Analyzed 12 12 13
Measure Type: Number
Unit of Measure: participants
<=0% 4 8 7
>0% to <5% 3 1 2
>=5% 5 3 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Hide Arm/Group Description Supportive care only VT-122 (dose of etodolac: 400 mg/day) + supportive care VT-122 (dose of etodolac: 800 mg/day) + supportive care
All-Cause Mortality
Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      4/12 (33.33%)      3/13 (23.08%)    
Blood and lymphatic system disorders       
Thrombocytopenia 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Anaemia 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Cardiac disorders       
Cardiorespiratory Failure 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
General disorders       
Disease Progression 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Death 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations       
Gastroenteritis 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Lower Respiratory Tract Infection 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nervous system disorders       
Headache 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Acute Respiratory Distress 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A, Control Group Group B, Low Dose VT-122 Group C, High Dose VT-122
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      9/12 (75.00%)      10/13 (76.92%)    
Blood and lymphatic system disorders       
Eosinophilia 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Leukocytosis 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Leukopenia 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Neutropenia  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Thrombocytopenia 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Cardiac disorders       
Bradycardia 1  0/12 (0.00%)  0 0/12 (0.00%)  0 2/13 (15.38%)  2
Sinus bradycardia 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Ear and labyrinth disorders       
Vertigo 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders       
Abdominal Pain 1  0/12 (0.00%)  0 1/12 (8.33%)  1 1/13 (7.69%)  1
Constipation 1  2/12 (16.67%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Diarrhea 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Dyspepsia 1  2/12 (16.67%)  2 0/12 (0.00%)  0 1/13 (7.69%)  1
Dysphagia 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Gastritis 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nausea 1  2/12 (16.67%)  2 1/12 (8.33%)  1 1/13 (7.69%)  1
Vomiting 1  1/12 (8.33%)  1 1/12 (8.33%)  1 1/13 (7.69%)  1
General disorders       
Asthenia 1  2/12 (16.67%)  2 1/12 (8.33%)  1 0/13 (0.00%)  0
Chest Pain 1  1/12 (8.33%)  1 2/12 (16.67%)  2 0/13 (0.00%)  0
Crepitations 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Fatigue 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Malaise 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Edema Peripheral 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Pyrexia 1  2/12 (16.67%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations       
Infection 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Nasopharyngitis 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications       
Tracheal Deviation 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Investigations       
Alanine Aminotransferase Increased (SGPT) 1  0/12 (0.00%)  0 2/12 (16.67%)  2 0/13 (0.00%)  0
Aspartate Aminotransferase Increased (SGOT) 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Blood Alkaline Phosphatase Increased 1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Blood Creatinine Increased 1  1/12 (8.33%)  1 1/12 (8.33%)  1 0/13 (0.00%)  0
Breath Sounds Abnormal 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Heart Rate Decreased 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Liver Palpable Subcostal 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Weight Decreased 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Metabolism and nutrition disorders       
Anorexia 1  2/12 (16.67%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthropathy 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Back Pain 1  1/12 (8.33%)  1 2/12 (16.67%)  2 2/13 (15.38%)  2
Muscle Atrophy 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Pain In Extremity 1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders       
Dizziness  0/12 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Headache 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders       
Hematuria 1  2/12 (16.67%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough 1  3/12 (25.00%)  3 2/12 (16.67%)  2 2/13 (15.38%)  2
Dyspnea 1  0/12 (0.00%)  0 1/12 (8.33%)  1 4/13 (30.77%)  4
Pleural Effusion 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders       
Hypotension 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Pallor 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, MedDRA (9.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Guarino
Organization: Oxford Pharmaceutical Resources, Inc.
Phone: 973-256-0600
EMail: Guarino@oxfordpharm.com
Layout table for additonal information
Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT00527319    
Other Study ID Numbers: VT-1 CAX-001
First Submitted: August 30, 2007
First Posted: September 10, 2007
Results First Submitted: November 8, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013