Regimen for the Treatment of Cachexia in Subjects With NSCLC (VT-122)
Primary Purpose
Cachexia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VT-122 low dose
VT-122 high dose
Sponsored by
About this trial
This is an interventional supportive care trial for Cachexia focused on measuring NSCLC, anorexia, cachexia, grip strength, lean body mass
Eligibility Criteria
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:
- 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
Sites / Locations
- First Dynamic Health Care Services, Inc.
- Rajalakshmi Nursing Home
- Nizam Institute of Medical Sciences
- Orchid Nursing Home
- Shatabdi Super Specialty Hospital
- All India Institute of Medical Sciences
- Indraprastha Apollo Hospital
- Deenanath Mangeshkar Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Group A, control group
Group B, Low Dose VT-122
Group C, High Dose VT-122
Arm Description
Supportive care only
VT-122 (dose of etodolac: 400 mg/day) + supportive care
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Outcomes
Primary Outcome Measures
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00527319
Brief Title
Regimen for the Treatment of Cachexia in Subjects With NSCLC
Acronym
VT-122
Official Title
A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vicus Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia
Keywords
NSCLC, anorexia, cachexia, grip strength, lean body mass
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A, control group
Arm Type
No Intervention
Arm Description
Supportive care only
Arm Title
Group B, Low Dose VT-122
Arm Type
Active Comparator
Arm Description
VT-122 (dose of etodolac: 400 mg/day) + supportive care
Arm Title
Group C, High Dose VT-122
Arm Type
Active Comparator
Arm Description
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Intervention Type
Drug
Intervention Name(s)
VT-122 low dose
Intervention Description
VT-122 low dose, dose escalated
Intervention Type
Drug
Intervention Name(s)
VT-122 high dose
Intervention Description
VT-122 high dose, dose escalated
Primary Outcome Measure Information:
Title
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Time Frame
4 weeks
Title
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Guarino, MD
Organizational Affiliation
Oxford Pharmaceutical Resources, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
First Dynamic Health Care Services, Inc.
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Rajalakshmi Nursing Home
City
Bangalore
Country
India
Facility Name
Nizam Institute of Medical Sciences
City
Hyderabaad
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
Country
India
Facility Name
Shatabdi Super Specialty Hospital
City
Nashik
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
Country
India
Facility Name
Deenanath Mangeshkar Hospital
City
Pune
Country
India
12. IPD Sharing Statement
Learn more about this trial
Regimen for the Treatment of Cachexia in Subjects With NSCLC
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