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

• ClinicalTrials.gov Identifier: NCT00527319
• Recruitment Status: Completed
• First Posted: September 10, 2007
• Results First Posted: January 30, 2013
• Last Update Posted: January 30, 2013
• Sponsor: Vicus Therapeutics
• Information provided by (Responsible Party): Vicus Therapeutics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cachexia	Drug: VT-122 low dose; Drug: VT-122 high dose	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (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
• Study Start Date: January 2007
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass [ Time Frame: 4 weeks ]
2. Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength [ Time Frame: 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

All India Institute of Medical Sciences

New Delhi, India

Indraprastha Apollo Hospital

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

• Responsible Party: Vicus Therapeutics
• ClinicalTrials.gov Identifier: NCT00527319
• Other Study ID Numbers: VT-1 CAX-001
• First Posted: September 10, 2007
• Results First Posted: January 30, 2013
• Last Update Posted: January 30, 2013
• Last Verified: December 2012

Keywords provided by Vicus Therapeutics:

NSCLC; anorexia; cachexia; grip strength; lean body mass

Additional relevant MeSH terms:

Wasting Syndrome; Cachexia; Weight Loss; Body Weight Changes; Body Weight; Thinness; Metabolic Diseases; Nutrition Disorders