Advanced Gastrointestinal CancerPhase 1/2TREAT-ME 1NCT02008539
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
A Phase 1/2 study testing MSC_apceth_101 in people with Advanced Gastrointestinal Cancer, run by Apceth GmbH & Co. KG at 1 site in Germany.
Trial summary
To evaluate the safety and tolerability of MSC_apceth_101. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Cancer
- What is being tested?
- MSC_apceth_101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to 7 Sep 2016
- Phase
- Phase 1/2
- 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
- Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
- Premature or scheduled termination of standard therapy
- Progressive disease as clinically assessed by the investigator
- Max. tumour lesion ≤ 5 cm
- Adequate organ function
- Ability of patient to understand character and individual consequences of clinical trial
- Age ≥ 18 years
- Written informed consent must be available before any study specific procedure is performed
Who cannot join
- Patients with severe heart diseases
- Clinical significant ischemic disease during the last 4 weeks before Visit 1
- Severe lung disease
- Symptomatic peritoneal carcinomatosis
- Symptomatic pleural or pericardial effusion
- Serious uncontrolled acute infections less than 3 weeks before Visit 1
Show all 12Show fewer
- Known dependency on alcohol or other drugs
- Patients requiring corticoids in doses above the Cushing threshold
- Known liver fibrosis or liver cirrhosis
- Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
- Female patient who is pregnant or breast feeding
- Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and tolerability of MSC_apceth_101.
- Conditions
- Advanced Gastrointestinal Cancer
- Being tested
- MSC_apceth_101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC_apceth_101Drug
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: MSC_apceth_101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
Measured: day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion7 Sep 2016
- Study completion7 Sep 2016
Why it stopped: Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apceth GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008539
- Sponsor's protocol ID
- MSC_apceth_101/1
- Acronym
- TREAT-ME 1
- Status last verified
- Mar 2017
- First submitted
- 28 Oct 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
- ClinicalTrials.gov ID
- NCT02008539
- Acronym / sponsor ID
- TREAT-ME 1 / MSC_apceth_101/1
- Conditions
- Advanced Gastrointestinal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Apceth GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 11 Dec 2013 (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.
To evaluate the safety and tolerability of MSC_apceth_101.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: MSC_apceth_101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
- Premature or scheduled termination of standard therapy
- Progressive disease as clinically assessed by the investigator
- Max. tumour lesion ≤ 5 cm
- Adequate organ function
Key exclusion criteria (12 listed)
- Patients with severe heart diseases
- Clinical significant ischemic disease during the last 4 weeks before Visit 1
- Severe lung disease
- Symptomatic peritoneal carcinomatosis
- Symptomatic pleural or pericardial effusion
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 |
|---|---|---|
| MSC_apceth_101 | Drug | treatment arm |
Primary outcome
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
Time frame: day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
Results and safety
The study was stopped early (reason given: Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC_apceth_101 in people with Advanced Gastrointestinal Cancer, run by Apceth GmbH & Co. KG at 1 site 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 8 inclusion and 12 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP). 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?
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute (time frame: day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2). 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 27 Mar 2017.