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

July 19, 2008 updated by: Anaborex

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
Time Frame: 25 weeks
25 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination
Time Frame: 25 weeks
25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anaborex

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANA-CTP0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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