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
  Purpose

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 Intervention Phase
Anorexia
Cachexia
Weight Loss
Carcinoma, Non-Small-Cell Lung
Drug: Betamarc
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anaborex:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2007
Estimated Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Betamarc
    2 tabs BID
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535015

Locations
China
Tuen Mun Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Cathay General Hospital
Taipei, Taiwan
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 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
  More Information

No publications provided

Responsible Party: Jeff Rudy, Vice President Clinical Operations, Anaborex, Inc.
ClinicalTrials.gov Identifier: NCT00535015     History of Changes
Other Study ID Numbers: ANA-CTP0002
Study First Received: September 23, 2007
Last Updated: July 19, 2008
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board
Korea: Food and Drug Administration
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Anorexia
Cachexia
Carcinoma
Carcinoma, Non-Small-Cell Lung
Weight Loss
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Body Weight Changes
Body Weight
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014