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

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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

Participant Flow

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
Arm/Group Description	Supportive care only	VT-122 low dose Supportive care	VT-122 high dose Supportive care
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

Baseline Characteristics

Arm/Group Title		Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122	Total
Arm/Group Description		Supportive care only	VT-122 (dose of etodolac: 400 mg/da...	VT-122 (dose of etodolac: 800 mg/da...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
India		12	12	13	37

Outcome Measures

1.Primary Outcome


Title	Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Description	[Not Specified]
Description	[Not Specified]
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
Arm/Group Description:	Supportive care only	VT-122 (dose of etodolac: 400 mg/da...	VT-122 (dose of etodolac: 800 mg/da...
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
Arm/Group Description:	Supportive care only	VT-122 (dose of etodolac: 400 mg/da...	VT-122 (dose of etodolac: 800 mg/da...
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

Adverse Events

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
Arm/Group Description	Supportive care only		VT-122 (dose of etodolac: 400 mg/da...		VT-122 (dose of etodolac: 800 mg/da...
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	--/--		--/--		--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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 History of Changes
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

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