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Sponsored by: |
Vicus Therapeutics |
Information provided by: | Vicus Therapeutics |
ClinicalTrials.gov Identifier: | NCT00527319 |
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 |
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 |
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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard A Guarino, MD | 973-256-0600 | guarino@oxfordpharm.com |
Contact: Robert D Allison, Ph.D | 254-754-0369 | fdhcsi@aol.com |
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 |
Vicus Therapeutics |
Study Director: | Richard A Guarino, MD | Oxford Pharmaceutical Resources, Inc. |
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 |
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