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

This study has been terminated.
(Objectives of study could not be met within a reasonable timeframe.)
Sponsor:
Information provided by:
Anaborex
ClinicalTrials.gov Identifier:
NCT00535015
First received: September 23, 2007
Last updated: July 19, 2008
Last verified: July 2008

September 23, 2007
July 19, 2008
October 2007
June 2008   (final data collection date for primary outcome measure)
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate [ Time Frame: 25 weeks ]
Complete list of historical versions of study NCT00535015 on ClinicalTrials.gov Archive Site
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination [ Time Frame: 25 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anorexia
  • Cachexia
  • Weight Loss
  • Carcinoma, Non-Small-Cell Lung
Drug: Betamarc
2 tabs BID
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
August 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Taiwan
 
NCT00535015
ANA-CTP0002
Yes
Jeff Rudy, Vice President Clinical Operations, Anaborex, Inc.
Anaborex
Not Provided
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 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 The Catholic University of Korea ST.Vincent's hospital
Principal Investigator: Jin-hyoung Kang The Catholic University of Korea, St. Mary's Hospital
Principal Investigator: Anita Zarina binti Bustam University Malaya Medical Centre
Principal Investigator: Abdul Razak bin Abdul Muttalif Hospital Pulau Pinang
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 Hospital
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
Anaborex
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP