CachexiaPhase 2VT-122NCT00527319
Regimen for the Treatment of Cachexia in Subjects With NSCLC
A Phase 2 study testing VT-122 low dose and VT-122 high dose in people with Cachexia, run by Vicus Therapeutics at 8 sites in 2 countries.
Trial summary
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia
- What is being tested?
- VT-122 low dose and VT-122 high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with NSCLC
- Demonstrating average weight loss of 5% within 2 months prior to enrollment
- Heart rate of 72 bpm or greater
- Negative pregnancy test (female patients of child bearing age)
- Able to give informed consent
- Able to be administered medication
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- Able to take food and defined nutritional support
- Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose
- Have not undergone surgery for at least 2 weeks prior to entry into trial
- Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial
- An expected survival for a minimum of 12 weeks
Who cannot join
- Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
- Blood pressure less than 100/65
- Weight loss of 15% within 2 months prior to recruitment
- Hypersensitivity reaction to the active components in VT-122
- History of myocardial infraction within the past 3 months
- Congestive heart failure (as determined by symptoms and ECG)
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- A-V block of second or third degree
- Unstable angina
- Uncontrolled diabetes
- Unable to be assessed for grip strength
- A positive pregnancy test
- Chronic infection or sepsis
- History of bleeding disorders
- Patients with peripheral edema
- Patients on digoxin or other chronotropic drugs
- Patients with evidence of severe dehydration
- Patients with evidence of ascites
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
India7 sites
Rajalakshmi Nursing Home
Bangalore
Nizam Institute of Medical Sciences
Hyderabaad
Orchid Nursing Home
Kolkata
Shatabdi Super Specialty Hospital
Nashik
All India Institute of Medical Sciences
New Delhi
Indraprastha Apollo Hospital
New Delhi
Deenanath Mangeshkar Hospital
Pune
United States1 site
First Dynamic Health Care Services, Inc.
Waco, Texas, 76708
About this study
Official title: A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.
To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.
Read the detailed description
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen
This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.
- Conditions
- Cachexia
- Being tested
- VT-122 low dose, VT-122 high dose
- Keywords
- NSCLC, anorexia, cachexia, grip strength, lean body mass
- Medical subject headings
- Cachexia, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-122 low doseDrug
VT-122 low dose, dose escalated
VT-122 high doseDrug
VT-122 high dose, dose escalated
| Study group | Role | What they receive |
|---|---|---|
| Group A, control group | No intervention | Supportive care only |
| Group B, Low Dose VT-122 | Active comparator | VT-122 (dose of etodolac: 400 mg/day) + supportive care Receives: Drug: VT-122 low dose |
| Group C, High Dose VT-122 | Active comparator | VT-122 (dose of etodolac: 800 mg/day) + supportive care Receives: Drug: VT-122 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Measured: 4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CachexiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicus Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Guarino, MD, Study director, Oxford Pharmaceutical Resources, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527319
- Sponsor's protocol ID
- VT-1 CAX-001
- Acronym
- VT-122
- Status last verified
- Dec 2012
- First submitted
- 30 Aug 2007
- Last updated
- 30 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00527319
- Acronym / sponsor ID
- VT-122 / VT-1 CAX-001
- Conditions
- Cachexia
- Keywords
- NSCLC, anorexia, cachexia, grip strength, lean body mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vicus TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.
To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.
Detailed description
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen
This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A, control group | No intervention | –Supportive care only |
| Group B, Low Dose VT-122 | Active comparator | Drug: VT-122 low doseVT-122 (dose of etodolac: 400 mg/day) + supportive care |
| Group C, High Dose VT-122 | Active comparator | Drug: VT-122 high doseVT-122 (dose of etodolac: 800 mg/day) + supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with NSCLC
- Demonstrating average weight loss of 5% within 2 months prior to enrollment
- Heart rate of 72 bpm or greater
- Negative pregnancy test (female patients of child bearing age)
- Able to give informed consent
Key exclusion criteria (17 listed)
- Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
- Blood pressure less than 100/65
- Weight loss of 15% within 2 months prior to recruitment
- Hypersensitivity reaction to the active components in VT-122
- History of myocardial infraction within the past 3 months
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 |
|---|---|---|
| VT-122 low doseVT-122 low dose, dose escalated | Drug | Group B, Low Dose VT-122 |
| VT-122 high doseVT-122 high dose, dose escalated | Drug | Group C, High Dose VT-122 |
Primary outcome
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Time frame: 4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard A Guarino, MD study director
Oxford Pharmaceutical Resources, Inc.
8 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 VT-122 low dose and VT-122 high dose in people with Cachexia, run by Vicus Therapeutics at 8 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 11 inclusion and 17 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: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India, United States. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 30 Jan 2013.