Hepatocellular CarcinomaPhase 2NCT00405873
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003
A Phase 2 study testing AMT2003 in people with Hepatocellular Carcinoma, run by Auron Healthcare GmbH at 2 sites in Germany.
Trial summary
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma The primary endpoint is best overall response rate within 20 weeks after registration Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AMT2003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2007to Mar 2010
- 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 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 of 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 method of birth control
- Confirmed diagnosis of HIV
- 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 study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Freiburg, Dept. of Internal Medicine II
Freiburg im Breisgau, Baaden-Wuerttemberg, 79106
Clinic SanaFontis
Freiburg im Breisgau, 79111
About this study
Official title: A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma
The primary endpoint is best overall response rate within 20 weeks after registration
Read the detailed description
The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.
The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AMT2003
- Keywords
- Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life
- Medical subject headings
- Carcinoma, Hepatocellular, 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.
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Measured: March 2010
Secondary outcomes (4)
Progression Free Survival (PFS) time
Measured: March 2010
Overall Survival (OS) time
Measured: March 2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Measured: March 2010
Safety and Tolerability
Measured: March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auron Healthcare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Blum, Prof. Dr. med. Dr. h. c., Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405873
- Sponsor's protocol ID
- AMT/P2GI/001 Part I
- Other IDs
- LC004AURON2005
- Status last verified
- Mar 2013
- First submitted
- 29 Nov 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, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003
- ClinicalTrials.gov ID
- NCT00405873
- Acronym / sponsor ID
- AMT/P2GI/001 Part I
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Auron Healthcare GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Nov 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 primary hepatocellular carcinoma
The primary endpoint is best overall response rate within 20 weeks after registration
Detailed description
The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.
The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 of at least 3 months
Key exclusion criteria (8 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 method of birth control
- Confirmed diagnosis of HIV
- Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
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
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Time frame: March 2010
4 secondary outcomes
Progression Free Survival (PFS) time
Time frame: March 2010
Overall Survival (OS) time
Time frame: March 2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Time frame: March 2010
Safety and Tolerability
Time frame: March 2010
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Now legally responsible for 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.
Hubert Blum, Prof. Dr. med. Dr. h. c. principal investigator
University Hospital Freiburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMT2003 in people with Hepatocellular Carcinoma, run by Auron Healthcare GmbH at 2 sites in Germany.
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 8 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 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 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: Lack of efficacy). 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?
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later (time frame: March 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.