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Regimen for the Treatment of Cachexia in Subjects With NSCLC

Information source: Vicus Therapeutics
Information obtained from ClinicalTrials.gov on February 12, 2009
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

Page last updated: February 12, 2009

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