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

This study is currently recruiting participants.
Verified by Vicus Therapeutics, September 2007

Sponsored by: Vicus Therapeutics
Information provided by: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT00527319
  Purpose

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 NSCLS who have hypercatabolic cachexia.


Condition Intervention Phase
Cachexia
Drug: VT-122 low dose
Drug: VT-122 high dose
Phase II

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by Vicus Therapeutics:

Primary Outcome Measures:
  • Dose tolerance efficacy [ Time Frame: One Year ]

Secondary Outcome Measures:
  • Quality of life and weight gain [ Time Frame: One Year ]

Estimated Enrollment:   60
Study Start Date:   January 2007
Estimated Study Completion Date:   February 2008

Arms Assigned Interventions
A: No Intervention
B: Active Comparator Drug: VT-122 low dose
C: Active Comparator Drug: VT-122 high dose

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527319

Contacts
Contact: Richard A Guarino, MD     973-256-0600     guarino@oxfordpharm.com    
Contact: Robert D Allison, Ph.D     254-754-0369     fdhcsi@aol.com    

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

Sponsors and Collaborators
Vicus Therapeutics

Investigators
Study Director:     Richard A Guarino, MD     Oxford Pharmaceutical Resources, Inc.    
  More Information


Study ID Numbers:   VT-1 CAX-001
First Received:   August 30, 2007
Last Updated:   September 24, 2007
ClinicalTrials.gov Identifier:   NCT00527319
Health Authority:   United States: Food and Drug Administration;   India: Ministry of Health

Keywords provided by Vicus Therapeutics:
NSCLC  
anorexia  
cachexia  
grip strength  
lean body mass  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Non-small cell lung cancer
Lung Neoplasms
Weight Loss
Body Weight Changes
Anorexia
Influenza, Human
Cachexia
Emaciation
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on October 16, 2008




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