CompletedNCT00527319VT-122Updated Jan 30, 2013Results posted

Regimen for the Treatment of Cachexia in Subjects With NSCLC

A Phase 2 interventional study of VT-122 low dose and VT-122 high dose in Cachexia, sponsored by Vicus Therapeutics. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-30.

Sponsored by Vicus Therapeutics · Phase 2, Interventional, and Supportive care

Phase: Phase 2
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.

To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

Read the detailed description

The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen

This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Conditions studied

Cachexia

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Keywords

NSCLC
anorexia
cachexia
grip strength
lean body mass

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

This study's enrollment of 37 is below the median of 58 across 130 interventional studies indexed under Wasting Syndrome.

Browse Wasting Syndrome studies →

Lead sponsor

Vicus Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects with NSCLC
Demonstrating average weight loss of 5% within 2 months prior to enrollment
Heart rate of 72 bpm or greater
Negative pregnancy test (female patients of child bearing age)
Able to give informed consent
Able to be administered medication
Able to take food and defined nutritional support
Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose
Have not undergone surgery for at least 2 weeks prior to entry into trial
Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial
An expected survival for a minimum of 12 weeks

Exclusion criteria

Exclusion Criteria:

Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
Blood pressure less than 100/65
Weight loss of 15% within 2 months prior to recruitment
Hypersensitivity reaction to the active components in VT-122
History of myocardial infraction within the past 3 months
Congestive heart failure (as determined by symptoms and ECG)
A-V block of second or third degree
Unstable angina
Uncontrolled diabetes
Unable to be assessed for grip strength
A positive pregnancy test
Chronic infection or sepsis
History of bleeding disorders
Patients with peripheral edema
Patients on digoxin or other chronotropic drugs
Patients with evidence of severe dehydration
Patients with evidence of ascites

Study design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

No intervention
Group A, control group
Supportive care only
Active comparator
Group B, Low Dose VT-122
VT-122 (dose of etodolac: 400 mg/day) + supportive care
Drug: VT-122 low dose
Active comparator
Group C, High Dose VT-122
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Drug: VT-122 high dose

Interventions

DrugVT-122 low dose
VT-122 low dose, dose escalated
DrugVT-122 high dose
VT-122 high dose, dose escalated

What researchers measure

Primary outcomes

Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Time frame: 4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Time frame: 4 weeks

Results

Posted Jan 30, 2013

Participant flow

First patient visit: March 23, 2007 Last patient visit: December 10, 2008

Participant flow — Overall Study
Milestone	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
Started	12	12	13
Completed	6	8	7
Not completed	6	4	6
Withdrew: Withdrawal by subject	5	0	1
Withdrew: Lost to follow-up	1	0	0
Withdrew: Death	0	3	1
Withdrew: Intercurrent medical illness	0	1	3
Withdrew: Adverse event	0	0	1

Outcome measures

PrimaryProportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass

Time frame:: 4 weeks
Reported as:: Number · participants

Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
participants	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
<=0%	8	6	5
>0% to <5%	3	3	3
>=5%	1	3	4
Data Missing	0	0	1

PrimaryProportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength

Time frame:: 4 weeks
Reported as:: Number · participants

Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
participants	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
<=0%	4 ± 4.03	8 ± 3.56	7 ± 6.25
>0% to <5%	3	1	2
>=5%	5	3	4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A, Control Group	—	0/12 (0%)	7/12 (58.3%)
Group B, Low Dose VT-122	—	4/12 (33.3%)	9/12 (75%)
Group C, High Dose VT-122	—	3/13 (23.1%)	10/13 (76.9%)

Most frequent serious events

Most frequent serious events
Event	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
ThrombocytopeniaBlood and lymphatic system disorders	0/12	1/12	0/13
GastroenteritisInfections and infestations	0/12	1/12	0/13
HeadacheNervous system disorders	0/12	1/12	0/13
Cardiorespiratory FailureCardiac disorders	0/12	1/12	0/13
AnaemiaBlood and lymphatic system disorders	0/12	1/12	0/13
Lower Respiratory Tract InfectionInfections and infestations	0/12	1/12	0/13
Disease ProgressionGeneral disorders	0/12	1/12	0/13
DeathGeneral disorders	0/12	0/12	1/13
Pleural EffusionRespiratory, thoracic and mediastinal disorders	0/12	0/12	1/13
Acute Respiratory DistressRespiratory, thoracic and mediastinal disorders	0/12	0/12	1/13

Most frequent other events

Showing 10 of 47

Most frequent other events
Event	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122
DyspneaRespiratory, thoracic and mediastinal disorders	0/12	1/12	4/13
CoughRespiratory, thoracic and mediastinal disorders	3/12	2/12	2/13
ConstipationGastrointestinal disorders	2/12	0/12	0/13
DyspepsiaGastrointestinal disorders	2/12	0/12	1/13
NauseaGastrointestinal disorders	2/12	1/12	1/13
AstheniaGeneral disorders	2/12	1/12	0/13
Chest PainGeneral disorders	1/12	2/12	0/13
PyrexiaGeneral disorders	2/12	0/12	0/13
Alanine Aminotransferase Increased (SGPT)Investigations	0/12	2/12	0/13
AnorexiaMetabolism and nutrition disorders	2/12	0/12	0/13

Baseline characteristics

Age Continuous
Age Continuous(years)	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122	Total
Mean	54.1 ± 12.0	55.1 ± 7.6	57.6 ± 10.4	55.7 ± 10.1

Sex: Female, Male
Sex: Female, Male(Participants)	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122	Total
Female	3	6	3	12
Male	9	6	10	25

Region of Enrollment
Region of Enrollment(participants)	Group A, Control Group	Group B, Low Dose VT-122	Group C, High Dose VT-122	Total
India	12	12	13	37

Study locations

8 sites

First Dynamic Health Care Services, Inc.
Waco, Texas 76708, United States
Rajalakshmi Nursing Home
Bangalore, India
Nizam Institute of Medical Sciences
Hyderabaad, India
Orchid Nursing Home
Kolkata, India
Shatabdi Super Specialty Hospital
Nashik, India
All India Institute of Medical Sciences
New Delhi, India
Indraprastha Apollo Hospital
New Delhi, India
Deenanath Mangeshkar Hospital
Pune, India

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00527319
Lead sponsor: Vicus Therapeutics
Responsible party: Sponsor
First posted: Sep 10, 2007
Start date: Jan 2007
Primary completion: Aug 2008
Completion: Sep 2008
Results posted: Jan 30, 2013
Last update: Jan 30, 2013

Study contacts

Richard A Guarino, MD

study director · Oxford Pharmaceutical Resources, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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