Cancer CachexiaPhase 2NCT01238107
A Clinical Study With MT-102 in Subjects With Cancer Cachexia
A Phase 2 study testing MT-102 in people with Cancer Cachexia, run by Akamis Bio at 18 sites in 3 countries.
Trial summary
A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- MT-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Apr 2011to May 2013
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients aged between 25 to 80 years of age and with a life expectancy of greater than 3 months as judged by the treating physician.
- 2. Confirmed diagnosis of one of:
- Non-curative stage III or stage IV Colorectal Cancer (CRC) not suitable for surgery, or b. Non-curative stage III or stage IV Non-small Cell Lung Cancer (NSCLC) not suitable for surgery;
- 3. Patients who are receiving or who have already received a course of chemotherapy, with or without radiotherapy or surgery, with one of the following regimes:
- For non-small cell lung cancer, a platinum based regimen b. For colorectal cancer, a 5FU or Irinotecan based regimen
- 4. Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
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- 5. Evidence of cachexia as judged by one of:
- ≥5% documented weight loss in the previous 12 months; or b. A subjective report of weight loss in the previous 12 months and a recorded body mass index (BMI) less than 20.0 kg/m2 c. Ongoing documented weight loss of at least 1kg in the week prior to day 0; or 1.25kg in the 2 weeks prior to day 0, or 1.5kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25.
- 6. At least two of the following:
- Subjective report of decreased muscle strength b. Subjective report of fatigue c. Subjective report of anorexia d. Abnormal biochemistry with one or more of the following: i. CRP > ULN (as per Central Lab normal value) ii. Anemia (< 12 g/dl) iii. Low serum albumin (< 3.2 g/dl) 7. Patients of childbearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives; an intrauterine device; male or female condoms; diaphragm or cervical cap with spermicide; or abstinence) prior to randomisation and must agree to continue using such precautions until the end of the 140 day safety follow up; 8. Willing and able to comply with the protocol and to complete the study period; 9. Willing to forego other forms of experimental treatment during the study; 10. Signed and dated informed consent, prior to receipt of any study medication or any study related procedures.
- 11. ECOG performance status 0, 1 or 2 12. Able to complete the performance tests (SCP, SMWT, SPPB, HGS) at the screening visit and with two consecutive pre-randomisation SMWT results that differ by no more than 30% from each other 13. At least 80% compliant during the placebo run in period
Who cannot join
- 1. Pregnancy or lactation at screen or baseline visit;
- ≥20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
- Age greater than 80 or less than 25 at baseline visit;
- Scheduled to start any new course of chemotherapy or to undergo a change in present chemotherapeutic regimen during the dose escalation phase of the study (the first three weeks after randomisation);
- Any surgical procedure within the past month or any planned surgical procedure;
- Any mechanical obstruction of the alimentary canal;
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- Any history or evidence of intractable vomiting;
- A history or clinical evidence of any hyperthyroidism, cirrhosis, hepatic failure, HIV, renal failure (as determined by a serum creatinine > 250µmol/l or > 2.83 mg/dl at screen) or active tuberculosis (as confirmed by sputum or other microbiological methods, within the last five years);
- Any physical, medical, socioeconomic or other non-cancer related cause for simple starvation, muscle wasting or weight loss;
- Receiving enteral tube feeding or parenteral nutrition at screening or baseline visit;
- Any clinical evidence of ascites or significant oedema or significant pleural effusion at screening or baseline visit;
- Current or planned treatment with
- Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use of dexamethasone around the time of chemotherapy are acceptable);
- Beta adrenergic blockers,
- Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),
- Alpha adrenergic blockers,
- Ivabradine (Coralan, Procoralan),
- 5HT agonists or antagonists e.g. SSRI's, , (short-term use around the time of chemotherapy are acceptable)
- MAOI's,
- Beta agonists, (short term or on-and -off use of inhaled broncho-dilators are acceptable)
- Amiodarone,
- Megestrol, Anabolic Steroids or any other prescription medication intended to increase appetite or to treat unintentional weight loss.
- Treatment with any investigational drug therapy within 28 days prior to the screening visit;
- Previous history of administration of pindolol or s-pindolol;
- History of allergy or reaction to any component of the MT 102/study drug formulation;
- History or presence of congestive heart failure (with LVEF <45%) or uncontrolled hypertension (with BP >160/95 mm Hg);
- Use of a pacemaker, implantable defibrillator, or internalized metal stent;
- Resting pulse rate less than 68 beats per minute or high degree conduction defect on the electrocardiogram;
- A resting supine systolic blood pressure less than 100 mm Hg.
- A history of bronchospasm and bronchial asthma;
- History or diagnosis of brain metastases
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
India9 sites
Vedanta Institute of Medical Science
Ahmedabad, Gujarat, 380009
Shree Krishna Hopsital
Anand, Gujarat, 388325
Kailash Cancer Hospital & Research Centre
Goraj, Gujarat, 391760
Kumaran Hospital Private Ltd
Kilpauk, Chennai, 10
TATA Memorial Hopsital
Mumbai, Maharashtra, 400012
Curie Manavta Cancer Centre
Nashik, Maharashtra, 422004
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, 422005
Dr Kamakshi Memorial Hospital
Pallikaranai, Chennai, 600100
Noble Hopsital
Pune, Pune, 411013
Malaysia8 sites
Hospital Sultahan Bahiyah
Alor Star, Kedha, 05460
Hospital Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
Universiti Malaya Medical
Jalan Baharu, Kuala Lumpur, 50603
International Islamic University Malaysia
Kuantan, Pahang, 25200
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Hospital Umum Sarawak
Kuching, Sarawak, 93586
Penang General Hopsital
Pulau Pinang, Pulau Pinang, 10990
Tuanku Ja'afar Hospital
Seremban, Negeri Sembilan, 70300
Germany1 site
Charite Hospital Virchow-Klinikum Campus
Berlin, State of Berlin, d-13352
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate Doses of MT-102 in Subjects With Cachexia Related to Stage III and IV Non-small Cell Lung Cancer and Colorectal Cancer
A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer
Read the detailed description
Cachexia is a wasting disease, associated with significant morbidity and mortality, accompanying a wide range of serious illnesses, for which there are currently no widely approved therapeutic agents. Cachexia is defined as weight loss, associated with a chronic underlying disease, of at least 5% in 12 months or less. It is associated with fatigue, loss of muscle strength, a low fat free index and neurohormonal and biochemical abnormalities.
Cancer cachexia occurs in about a third of all patients with cancer and has been estimated to be the direct cause of death in up to 20% of all cancer related deaths. As with other solid tumours, colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) have relatively high incidences of cachexia, approximately 28% and 34% respectively.Through its combined pharmacological actions, MT-102 has a multi-functional effect upon three potential pharmacological targets, each of which is relevant for cancer cachexia
- Conditions
- Cancer Cachexia
- Being tested
- MT-102
- Keywords
- Cachexia, Cancer
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-102Drug
BETA BLOCKER
| Study group | Role | What they receive |
|---|---|---|
| High dose | Experimental | Not described Receives: Drug: MT-102 |
| Low dose | Experimental | Not described Receives: Drug: MT-102 |
| Placebo | Placebo comparator | Not described Receives: Drug: MT-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akamis Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veeda Oncology
- Responsible party
- Sponsor
- Investigators
- Kumar n Pradhash, MD, Principal investigator, TATA MEMORIAL HOSPITAL , MUMBAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238107
- Sponsor's protocol ID
- MT-102-2001
- Status last verified
- Sep 2014
- First submitted
- 9 Nov 2010
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate Doses of MT-102 in Subjects With Cachexia Related to Stage III and IV Non-small Cell Lung Cancer and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01238107
- Acronym / sponsor ID
- MT-102-2001
- Conditions
- Cancer Cachexia
- Keywords
- Cachexia, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Akamis BioIndustry (pharma, biotech, devices)
- Collaborators
- Veeda Oncology
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Nov 2010 (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.
A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer
Detailed description
Cachexia is a wasting disease, associated with significant morbidity and mortality, accompanying a wide range of serious illnesses, for which there are currently no widely approved therapeutic agents. Cachexia is defined as weight loss, associated with a chronic underlying disease, of at least 5% in 12 months or less. It is associated with fatigue, loss of muscle strength, a low fat free index and neurohormonal and biochemical abnormalities.
Cancer cachexia occurs in about a third of all patients with cancer and has been estimated to be the direct cause of death in up to 20% of all cancer related deaths. As with other solid tumours, colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) have relatively high incidences of cachexia, approximately 28% and 34% respectively.Through its combined pharmacological actions, MT-102 has a multi-functional effect upon three potential pharmacological targets, each of which is relevant for cancer cachexia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose | Experimental | Drug: MT-102 |
| Low dose | Experimental | Drug: MT-102 |
| Placebo | Placebo comparator | Drug: MT-102 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Adult patients aged between 25 to 80 years of age and with a life expectancy of greater than 3 months as judged by the treating physician.
- 3. Patients who are receiving or who have already received a course of chemotherapy, with or without radiotherapy or surgery, with one of the following regimes:
- 4. Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
- 11. ECOG performance status 0, 1 or 2 12. Able to complete the performance tests (SCP, SMWT, SPPB, HGS) at the screening visit and with two consecutive pre-randomisation SMWT results that differ by no more than 30% from each other 13. At least 80% compliant during the placebo run in period
Key exclusion criteria (31 listed)
- 1. Pregnancy or lactation at screen or baseline visit;
- ≥20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
- Age greater than 80 or less than 25 at baseline visit;
- Scheduled to start any new course of chemotherapy or to undergo a change in present chemotherapeutic regimen during the dose escalation phase of the study (the first three weeks after randomisation);
- Any surgical procedure within the past month or any planned surgical procedure;
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 |
|---|---|---|
| MT-102BETA BLOCKER | Drug | High dose, Low dose, Placebo |
Primary outcome
Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
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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.
Kumar n Pradhash, MD principal investigator
TATA MEMORIAL HOSPITAL , MUMBAI
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-102 in people with Cancer Cachexia, run by Akamis Bio at 18 sites in 3 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 31 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 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India, Malaysia, Germany. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer (time frame: 16 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 10 Sep 2014.