AnorexiaPhase 2NCT00535015
Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer
A Phase 2 study testing Betamarc in people with Anorexia and Cachexia, run by Anaborex at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia, Cachexia, Weight Loss
- What is being tested?
- Betamarc
- How many people
- 70 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate bone marrow, liver and renal function.
- Normal serum potassium.
- Ability to comply with the study requirements and give written informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan4 sites
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Cathay General Hospital
Taipei
Taipei Medical University Muncipal Wan Fang Hospital
Taipei
About this study
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
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
- Being tested
- Betamarc
- Medical subject headings
- Anorexia, Cachexia, Weight Loss, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamarcDrug
2 tabs BID
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
Measured: 25 weeks
Secondary outcomes (1)
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionAug 2008 (estimated)
Why it stopped: Objectives of study could not be met within a reasonable timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anaborex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yung-chuan Sung, Principal investigator, Cathay General HospitalHsing-jin Eugene Liu, Principal investigator, Taipei Medical University Muncipal Wan Fang HospitalTe-chun Hsia, Principal investigator, China Medical University HospitalGee-chen Chang, Principal investigator, Taichung Veterans General HospitalYao-kuang Wu, Principal investigator, Tzu Chi General Hospital Taipei BranchKwok-keung Yuen, Principal investigator, Tuen Mun HospitalDaniel Chua, Principal investigator, Queen Mary Hospital, Hong KongChung-kong Kwan, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535015
- Sponsor's protocol ID
- ANA-CTP0002
- Status last verified
- Jul 2008
- First submitted
- 23 Sep 2007
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00535015
- Acronym / sponsor ID
- ANA-CTP0002
- Conditions
- Anorexia, Cachexia, Weight Loss, Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Objectives of study could not be met within a reasonable timeframe.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AnaborexIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (estimated)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamarc2 tabs BID | Drug | – |
Primary outcome
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
Time frame: 25 weeks
1 secondary outcome
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination
Time frame: 25 weeks
Results and safety
The study was stopped early (reason given: Objectives of study could not be met within a reasonable timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yung-chuan Sung principal investigator
Cathay General Hospital
Hsing-jin Eugene Liu principal investigator
Taipei Medical University Muncipal Wan Fang Hospital
Te-chun Hsia principal investigator
China Medical University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamarc in people with Anorexia and Cachexia, run by Anaborex at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Objectives of study could not be met within a reasonable timeframe.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008.