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.

Study Overview

• Status: Terminated
• Conditions: Anorexia; Carcinoma, Non-Small-Cell Lung; Weight Loss; Cachexia
• Intervention / Treatment: Drug: Betamarc

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Elizabeth Hospital
  • Hong Kong, China
    • Tuen Mun Hospital
• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • Cathay General Hospital
  • Taipei, Taiwan
    • Taipei Medical University Muncipal Wan Fang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate	25 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination	25 weeks

Collaborators and Investigators

• Sponsor: Anaborex
• Investigators: Principal Investigator: Wu-chou Su, National Cheng-Kung University Hospital; 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: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: September 23, 2007
• First Submitted That Met QC Criteria: September 23, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): July 22, 2008
• Last Update Submitted That Met QC Criteria: July 19, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Signs and Symptoms, Digestive; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Body Weight Changes; Lung Neoplasms; Emaciation; Anorexia; Carcinoma, Non-Small-Cell Lung; Weight Loss; Cachexia
• Other Study ID Numbers: ANA-CTP0002