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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vicus Therapeutics
ClinicalTrials.gov Identifier:
NCT00527319
First received: August 30, 2007
Last updated: December 19, 2012
Last verified: December 2012

August 30, 2007
December 19, 2012
January 2007
August 2008   (final data collection date for primary outcome measure)
  • Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Dose tolerance efficacy [ Time Frame: One Year ]
Complete list of historical versions of study NCT00527319 on ClinicalTrials.gov Archive Site
Not Provided
Quality of life and weight gain [ Time Frame: One Year ]
Not Provided
Not Provided
 
Regimen for the Treatment of Cachexia in Subjects With NSCLC
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cachexia
  • Drug: VT-122 low dose
    VT-122 low dose, dose escalated
  • Drug: VT-122 high dose
    VT-122 high dose, dose escalated
  • 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
    Intervention: Drug: VT-122 low dose
  • Active Comparator: Group C, High Dose VT-122
    VT-122 (dose of etodolac: 800 mg/day) + supportive care
    Intervention: Drug: VT-122 high dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00527319
VT-1 CAX-001
Yes
Vicus Therapeutics
Vicus Therapeutics
Not Provided
Study Director: Richard A Guarino, MD Oxford Pharmaceutical Resources, Inc.
Vicus Therapeutics
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP