Regimen for the Treatment of Cachexia in Subjects With NSCLC

Cachexia Clinical Trial

— VT-122  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527319
• Other study ID #: VT-1 CAX-001
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2007
• Last updated: December 19, 2012
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2012
• Source: Vicus Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cachexia

Intervention

Drug:
• VT-122 low dose
VT-122 low dose, dose escalated
• VT-122 high dose
VT-122 high dose, dose escalated

Locations

Country	Name	City	State
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
United States	First Dynamic Health Care Services, Inc.	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vicus Therapeutics

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass		4 weeks	No
Primary	Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength		4 weeks	No