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

NCT00535015 | Terminated Phase 2 DMC

• 1 other identifier: ANA-CTP0002
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 6

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.

Conditions

Anorexia; Cachexia; Weight Loss; Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

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

  25 weeks

Secondary Outcomes (1)

• Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination

  25 weeks

Interventions

Betamarc DRUG

2 tabs BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anaborex: lead

Study Sites (6)

Queen Elizabeth Hospital

Hong Kong, China

Location

Tuen Mun Hospital

Hong Kong, China

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Cathay General Hospital

Taipei, Taiwan

Location

Taipei Medical University Muncipal Wan Fang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Anorexia; Cachexia; Weight Loss; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Thinness; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 23, 2007
• First Posted: September 26, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-07

Locations

CN (2); TW (4)