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
  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 NSCLC who have hypercatabolic cachexia.


Condition Intervention Phase
Cachexia
Drug: VT-122 low dose
Drug: VT-122 high dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Vicus Therapeutics:

Primary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: VT-122 low dose
VT-122 low dose, dose escalated
Active Comparator: Group C, High Dose VT-122
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Drug: VT-122 high dose
VT-122 high dose, dose escalated

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
First Dynamic Health Care Services, Inc.
Waco, Texas, United States, 76708
India
Rajalakshmi Nursing Home
Bangalore, India
Nizam Institute of Medical Sciences
Hyderabaad, India
Orchid Nursing Home
Kolkata, India
Shatabdi Super Specialty Hospital
Nashik, India
Indraprastha Apollo Hospital
New Delhi, India
All India Institute of Medical Sciences
New Delhi, India
Deenanath Mangeshkar Hospital
Pune, India
Sponsors and Collaborators
Vicus Therapeutics
Investigators
Study Director: Richard A Guarino, MD Oxford Pharmaceutical Resources, Inc.
  More Information

No publications provided

Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT00527319     History of Changes
Other Study ID Numbers: VT-1 CAX-001
Study First Received: August 30, 2007
Results First Received: November 8, 2012
Last Updated: December 19, 2012
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

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014