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

NCT ID: NCT00535015

Last Updated: 2008-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Betamarc

2 tabs BID

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anaborex

INDUSTRY

Sponsor Role lead

Responsible Party

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Anaborex, Inc.

Principal Investigators

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Yung-chuan Sung

Role: PRINCIPAL_INVESTIGATOR

Cathay General Hospital

Hsing-jin Eugene Liu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Muncipal Wan Fang Hospital

Te-chun Hsia

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Gee-chen Chang

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Yao-kuang Wu

Role: PRINCIPAL_INVESTIGATOR

Tzu Chi General Hospital Taipei Branch

Kwok-keung Yuen

Role: PRINCIPAL_INVESTIGATOR

Tuen Mun Hospital

Daniel Chua

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Chung-kong Kwan

Role: PRINCIPAL_INVESTIGATOR

The Queen Elizabeth Hospital

Kwok-chi Lam

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Dae-ho Lee

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Jong-seok Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hosptial

Hoon-kyo Kim

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent's Hospital, Korea

Jin-hyoung Kang

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea, St. Mary's Hospital

Anita Zarina binti Bustam

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Abdul Razak bin Abdul Muttalif

Role: PRINCIPAL_INVESTIGATOR

Penang Hospital, Malaysia

Biswa Mohan Biswal

Role: PRINCIPAL_INVESTIGATOR

Hospital Universiti Sains Malaysia

Wu-chou Su

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Ming-lin Ho

Role: PRINCIPAL_INVESTIGATOR

Chunghua Christian Hospital

Chang-yao Tsao

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Cheng-ta Yang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi

Wen-Tsung Huang

Role: PRINCIPAL_INVESTIGATOR

Chi Mei Medical Center Liou-Ying Campus

Edy Suratman

Role: PRINCIPAL_INVESTIGATOR

Dharmais Cancer Hospital

Elisna Syahruddin

Role: PRINCIPAL_INVESTIGATOR

Persahabatan Hospital

Alexander Ginting

Role: PRINCIPAL_INVESTIGATOR

Gatot Subroto Central Army Hospital

Locations

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Queen Elizabeth Hospital

Hong Kong, , China

Site Status

Tuen Mun Hospital

Hong Kong, , China

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Cathay General Hospital

Taipei, , Taiwan

Site Status

Taipei Medical University Muncipal Wan Fang Hospital

Taipei, , Taiwan

Site Status

Countries

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Indonesia Malaysia South Korea China Taiwan

Other Identifiers

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ANA-CTP0002

Identifier Type: -

Identifier Source: org_study_id