Regimen for the Treatment of Cachexia in Subjects With NSCLC
Information source: Vicus Therapeutics
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cachexia
Intervention: VT-122 low dose (Drug); VT-122 high dose (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Vicus Therapeutics Official(s) and/or principal investigator(s):
Richard A Guarino, MD, Study Director, Affiliation: Oxford Pharmaceutical Resources, Inc.
Overall contact:
Richard A Guarino, MD, Phone: 973-256-0600, Email: guarino@oxfordpharm.com
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 NSCLS who have hypercatabolic cachexia.
Clinical Details
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 design: Supportive Care, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Dose tolerance efficacy
Secondary outcome: Quality of life and weight gain
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Richard A Guarino, MD, Phone: 973-256-0600, Email: guarino@oxfordpharm.com
Deenanath Mangeshkar Hospital, Pune, India; Recruiting
Orchid Nursing Home, Kolkata, India; Recruiting
Nizam Institute of Medical Sciences, Hyderabad, India; Recruiting
All India Institute of Medical Sciences, New Delhi, India; Recruiting
Indraprastha Apollo Hospital, New Delhi, India; Recruiting
Rajalakshmi Nursing Home, Bangalore, India; Recruiting
Shatabdi Super Specialty Hospital, Nashik, India; Recruiting
First Dynamic Health Care Services, Inc., Waco, Texas 76708, United States; Recruiting
Additional Information
Starting date: January 2007
Ending date: February 2008
Last updated: September 24, 2007
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