Gastrointestinal CancerPhase 2/3NCT00332280
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
A Phase 2/3 study testing AMT2003 in people with Gastrointestinal Cancer and Prostate Cancer, run by Auron Healthcare GmbH at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female
- What is being tested?
- AMT2003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Mar 2010
- Phase
- Phase 2/3
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer confirmed by histology or cytology
- At least one measurable lesion
- Advanced disease refractory to standard therapy or for which no standard therapy exists
- Life expectancy at least 3 months
Who cannot join
- Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
- Body weight below 45 kg
- Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
- Concurrent severe or uncontrolled medical disease
- Acute or chronic liver disease
- Confirmed diagnosis of HIV
Show all 10Show fewer
- Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
- Chemotherapy or radiotherapy less than 4 weeks prior to entry
- Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
- Participation in a clinical trial less than 30 days prior to entry into this study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Bosnia and Herzegovina1 site
Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
Sarajevo
About this study
Official title: A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.
The primary evaluation criterion is clinical benefit response.
Read the detailed description
The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.)
The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.
- Being tested
- AMT2003
- Keywords
- solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, prostate cancer, gynecological cancer, lung cancer, Tumors of GI tract, prostate and gynaecological
- Medical subject headings
- Gastrointestinal Neoplasms, Prostatic Neoplasms, Genital Neoplasms, Female, Esophageal Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT2003Drug
| Study group | Role | What they receive |
|---|---|---|
| AMT2003 | Experimental | Not described Receives: Drug: AMT2003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in clinical benefit response
Measured: Jan 2010
Secondary outcomes (6)
Progression free survival
Measured: Jan 2010
Overall survival
Measured: Jan 2010
Overall response rate
Measured: 2010
Duration of response
Measured: January 2010
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
Measured: Jan 2010
Safety and tolerability
Measured: Jan 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2010
- Study completionMar 2010
Why it stopped: Lack of efficacy. Stopped at first interim evaluation point
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auron Healthcare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Drevs, PD Dr. Med, Principal investigator, Clinic SanaFontis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332280
- Sponsor's protocol ID
- AMT/P2CA/001
- Other IDs
- LC003AURON2005
- Status last verified
- Mar 2013
- First submitted
- 31 May 2006
- Last updated
- 20 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
- ClinicalTrials.gov ID
- NCT00332280
- Acronym / sponsor ID
- AMT/P2CA/001
- Keywords
- solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy. Stopped at first interim evaluation point
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Auron Healthcare GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Jun 2006 (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 the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.
The primary evaluation criterion is clinical benefit response.
Detailed description
The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.)
The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMT2003 | Experimental | Drug: AMT2003 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer confirmed by histology or cytology
- At least one measurable lesion
- Advanced disease refractory to standard therapy or for which no standard therapy exists
- Life expectancy at least 3 months
Key exclusion criteria (10 listed)
- Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
- Body weight below 45 kg
- Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
- Concurrent severe or uncontrolled medical disease
- Acute or chronic liver disease
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 |
|---|---|---|
| AMT2003 | Drug | AMT2003 |
Primary outcome
Improvement in clinical benefit response
Time frame: Jan 2010
6 secondary outcomes
Progression free survival
Time frame: Jan 2010
Overall survival
Time frame: Jan 2010
Overall response rate
Time frame: 2010
Duration of response
Time frame: January 2010
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
Time frame: Jan 2010
Safety and tolerability
Time frame: Jan 2010
Results and safety
The study was stopped early (reason given: Lack of efficacy. Stopped at first interim evaluation point). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Alpinia Institute now legally responsible for the studyLink provided by the sponsor.
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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.
Joachim Drevs, PD Dr. Med principal investigator
Clinic SanaFontis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AMT2003 in people with Gastrointestinal Cancer and Prostate Cancer, run by Auron Healthcare GmbH at 2 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 4 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 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bosnia and Herzegovina, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Lack of efficacy. Stopped at first interim evaluation point). 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?
Improvement in clinical benefit response (time frame: Jan 2010). 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 20 Mar 2013.