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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527319
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Vicus Therapeutics

Tracking Information
First Submitted Date  ICMJE August 30, 2007
First Posted Date  ICMJE September 10, 2007
Results First Submitted Date  ICMJE November 8, 2012
Results First Posted Date  ICMJE January 30, 2013
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
Dose tolerance efficacy [ Time Frame: One Year ]
Change History Complete list of historical versions of study NCT00527319 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2007)
Quality of life and weight gain [ Time Frame: One Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Regimen for the Treatment of Cachexia in Subjects With NSCLC
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cachexia
Intervention  ICMJE
  • Drug: VT-122 low dose
    VT-122 low dose, dose escalated
  • Drug: VT-122 high dose
    VT-122 high dose, dose escalated
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2007)
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00527319
Other Study ID Numbers  ICMJE VT-1 CAX-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vicus Therapeutics
Study Sponsor  ICMJE Vicus Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard A Guarino, MD Oxford Pharmaceutical Resources, Inc.
PRS Account Vicus Therapeutics
Verification Date December 2012

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