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

Sponsor

Anaborex (Industry)

Overall Status

Terminated

CT.gov ID

NCT00535015

Collaborator

(none)

Enrollment

Locations

Duration (Months)

11.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia Weight Loss Carcinoma, Non-Small-Cell Lung	Drug: Betamarc	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Anticipated Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate [25 weeks]

Secondary Outcome Measures

Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination [25 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Queen Elizabeth Hospital	Hong Kong	China
2	Tuen Mun Hospital	Hong Kong	China
3	China Medical University Hospital	Taichung	Taiwan
4	Taichung Veterans General Hospital	Taichung	Taiwan
5	Cathay General Hospital	Taipei	Taiwan
6	Taipei Medical University Muncipal Wan Fang Hospital	Taipei	Taiwan

Sponsors and Collaborators

Anaborex

Investigators

Principal Investigator: Yung-chuan Sung, Cathay General Hospital
Principal Investigator: Hsing-jin Eugene Liu, Taipei Medical University Muncipal Wan Fang Hospital
Principal Investigator: Te-chun Hsia, China Medical University Hospital
Principal Investigator: Gee-chen Chang, Taichung Veterans General Hospital
Principal Investigator: Yao-kuang Wu, Tzu Chi General Hospital Taipei Branch
Principal Investigator: Kwok-keung Yuen, Tuen Mun Hospital
Principal Investigator: Daniel Chua, Queen Mary Hospital, Hong Kong
Principal Investigator: Chung-kong Kwan, The Queen Elizabeth Hospital
Principal Investigator: Kwok-chi Lam, Prince of Wales Hospital
Principal Investigator: Dae-ho Lee, Asan Medical Center
Principal Investigator: Jong-seok Lee, Seoul National University Bundang Hosptial
Principal Investigator: Hoon-kyo Kim, Saint Vincent's Hospital, Korea
Principal Investigator: Jin-hyoung Kang, The Catholic University of Korea, St. Mary's Hospital
Principal Investigator: Anita Zarina binti Bustam, University of Malaya
Principal Investigator: Abdul Razak bin Abdul Muttalif, Penang Hospital, Malaysia
Principal Investigator: Biswa Mohan Biswal, Hospital Universiti Sains Malaysia
Principal Investigator: Wu-chou Su, National Cheng-Kung University Hospital
Principal Investigator: Ming-lin Ho, Chunghua Christian Hospital
Principal Investigator: Chang-yao Tsao, Chung Shan Medical University
Principal Investigator: Cheng-ta Yang, Chang-Gung Memorial Hospital--Chiayi
Principal Investigator: Wen-Tsung Huang, Chi Mei Medical Center Liou-Ying Campus
Principal Investigator: Edy Suratman, Dharmais Cancer Hospital
Principal Investigator: Elisna Syahruddin, Persahabatan Hospital
Principal Investigator: Alexander Ginting, Gatot Subroto Central Army Hospital