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Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

Primary Purpose

Anorexia, Cachexia, Weight Loss

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Betamarc

About this trial

This is an interventional treatment trial for Anorexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.
Treatment plan includes a platinum-based doublet chemotherapy.
ECOG 0, 1 or 2.
Self-reported loss of body weight or anorexia.
Serum C-reactive protein ≥5 mg/L.
Life expectancy of at least 6 months.
Adequate bone marrow, liver and renal function.
Normal serum potassium.
Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.
Concomitant therapy with an appetite stimulant.
History of poorly controlled hypertension or congestive heart failure.
Any implanted devices that could interfere with DXA scanning.
Prolongation of QT interval.
History of additional risk factors for torsades de pointe.
Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.
Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.
Any second malignancy which might confound the interpretation of safety or efficacy assessments.
Any condition which increases the patient's risk for participating in the study.

Sites / Locations

Queen Elizabeth Hospital
Tuen Mun Hospital
China Medical University Hospital
Taichung Veterans General Hospital
Cathay General Hospital
Taipei Medical University Muncipal Wan Fang Hospital

Outcomes

Primary Outcome Measures

Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate

Secondary Outcome Measures

Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination

Full Information

NCT ID

NCT00535015

First Posted

September 23, 2007

Last Updated

July 19, 2008

Sponsor

Anaborex

1. Study Identification

Unique Protocol Identification Number

NCT00535015

Brief Title

Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

Official Title

A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Terminated

Why Stopped

Objectives of study could not be met within a reasonable timeframe.

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Anaborex

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia, Cachexia, Weight Loss, Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Betamarc

Intervention Description

2 tabs BID

Primary Outcome Measure Information:

Title

Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate

Time Frame

25 weeks

Secondary Outcome Measure Information:

Title

Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination

Time Frame

25 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery. Treatment plan includes a platinum-based doublet chemotherapy. ECOG 0, 1 or 2. Self-reported loss of body weight or anorexia. Serum C-reactive protein ≥5 mg/L. Life expectancy of at least 6 months. Adequate bone marrow, liver and renal function. Normal serum potassium. Ability to comply with the study requirements and give written informed consent. Exclusion Criteria: Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product. Concomitant therapy with an appetite stimulant. History of poorly controlled hypertension or congestive heart failure. Any implanted devices that could interfere with DXA scanning. Prolongation of QT interval. History of additional risk factors for torsades de pointe. Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives. Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control. Any second malignancy which might confound the interpretation of safety or efficacy assessments. Any condition which increases the patient's risk for participating in the study.

Overall Study Officials: