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
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia
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.
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
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
No
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:
First Name & Middle Initial & Last Name & Degree
Yung-chuan Sung
Organizational Affiliation
Cathay General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hsing-jin Eugene Liu
Organizational Affiliation
Taipei Medical University Muncipal Wan Fang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Te-chun Hsia
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gee-chen Chang
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yao-kuang Wu
Organizational Affiliation
Tzu Chi General Hospital Taipei Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwok-keung Yuen
Organizational Affiliation
Tuen Mun Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Chua
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chung-kong Kwan
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwok-chi Lam
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae-ho Lee
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-seok Lee
Organizational Affiliation
Seoul National University Bundang Hosptial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoon-kyo Kim
Organizational Affiliation
Saint Vincent's Hospital, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-hyoung Kang
Organizational Affiliation
The Catholic University of Korea, St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anita Zarina binti Bustam
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdul Razak bin Abdul Muttalif
Organizational Affiliation
Penang Hospital, Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Biswa Mohan Biswal
Organizational Affiliation
Hospital Universiti Sains Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wu-chou Su
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming-lin Ho
Organizational Affiliation
Chunghua Christian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang-yao Tsao
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheng-ta Yang
Organizational Affiliation
Chang-Gung Memorial Hospital--Chiayi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen-Tsung Huang
Organizational Affiliation
Chi Mei Medical Center Liou-Ying Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edy Suratman
Organizational Affiliation
Dharmais Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisna Syahruddin
Organizational Affiliation
Persahabatan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Ginting
Organizational Affiliation
Gatot Subroto Central Army Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
China
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Medical University Muncipal Wan Fang Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer
We'll reach out to this number within 24 hrs