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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535015
• Other study ID #: ANA-CTP0002
• Status: Terminated
• Phase: Phase 2
• First received: September 23, 2007
• Last updated: July 19, 2008
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2008
• Source: Anaborex
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review BoardKorea: Food and Drug AdministrationHong Kong: Department of HealthHong Kong: Ethics CommitteeHong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Betamarc
2 tabs BID

Locations

Country	Name	City	State
China	Queen Elizabeth Hospital	Hong Kong
China	Tuen Mun Hospital	Hong Kong
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Cathay General Hospital	Taipei
Taiwan	Taipei Medical University Muncipal Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Anaborex

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate		25 weeks	No
Secondary	Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination		25 weeks	Yes