Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cachexia

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Richard A Guarino, MD

Investigator Role:

Study Director

Investigator Affiliation:

Oxford Pharmaceutical Resources, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

VT-1 CAX-001

NCT ID:

NCT00527319

Start Date:

January 2007

Completion Date:

September 2008

Related Keywords:

  • Cachexia
  • NSCLC
  • anorexia
  • cachexia
  • grip strength
  • lean body mass
  • Cachexia

Name

Location

First Dynamic Health Care Services, Inc.Waco, Texas  76708