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
18 Years
N/A
Both
Cachexia
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
Richard A Guarino, MD
Investigator Role:
Study Director
Investigator Affiliation:
Oxford Pharmaceutical Resources, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
VT-1 CAX-001
NCT ID:
NCT00527319
Start Date:
January 2007
Completion Date:
September 2008
Related Keywords:
- Cachexia
- NSCLC
- anorexia
- cachexia
- grip strength
- lean body mass
- Cachexia
Name | Location |
|---|---|
| First Dynamic Health Care Services, Inc. | Waco, Texas 76708 |
