Liver MetastasesPhase 2MT201-204NCT00866944
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
A Phase 2 study testing Adecatumumab, Adecatumumab and FOLFOX and FOLFOX 4 in people with Liver Metastases and Colorectal Cancer, run by Amgen Research (Munich) GmbH at 16 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Colorectal Cancer
- What is being tested?
- Adecatumumab, Adecatumumab and FOLFOX and FOLFOX 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Mar 2009to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma
- Age ≥18 years
- ECOG performance status ≤ 2
- Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent
Who cannot join
- Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
- Neoadjuvant chemotherapy of liver metastases prior to surgery
- Any anticancer chemotherapy within 4 weeks prior to study entry
- Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
- Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
- Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
Show all 21Show fewer
- Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
- Acute or chronic pancreatitis or history of alcohol induced pancreatitis
- Liver cirrhosis, acute hepatitis or chronic hepatic disease
- Any unresolved complications from prior surgery
- Persistent neuropathy
- History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
- History of inflammatory bowel disease
- Active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
- Use of immune-suppressive agents such as the regular use of systemic corticosteroids
- HIV positivity
- Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
- Pregnant or nursing women
- Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
- Not willing or incapable to comply with all study visits and assessments
- Placed into an institution due to juridical or regulatory ruling
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Germany15 sites
Zentralklinikum Augsburg
Augsburg, 86156
Klinikum am Bruderwald, Sozialstiftung Bamberg
Bamberg, 96049
Charité Campus Virchow Klinikum
Berlin, 13353
Klinikum der Heinrich-Heine Universität
Düsseldorf, 40489
J.W. Goethe-Universität
Frankfurt, 60590
Martin-Luther Universität
Halle, 06120
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Leipzig
Leipzig, 04103
Klinikum Magdeburg gGmbH
Magdeburg, 39130
Klinikum der Johannes-Gutenberg Universität
Mainz, 55131
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167
Universitätsklinikum der LMU Grosshadern
München, 81377
Städtisches Klinikum Neuperlach
München, 81737
Klinikum Oldenburg gGmbH
Oldenburg, 26133
Klinikum der Universität Regensburg
Regensburg, 93053
About this study
Official title: A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.
- Conditions
- Liver Metastases, Colorectal Cancer
- Being tested
- Adecatumumab, Adecatumumab and FOLFOX, FOLFOX 4
- Keywords
- Colorectal carcinoma, Liver metastases (only), R0 resection, R0 resection of liver metastases from colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdecatumumabDrug
Also called MT201
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
Adecatumumab and FOLFOXDrug
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
FOLFOX 4Drug
FOLFOX 4, every 14 days, 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adecatumumab alone Receives: Drug: Adecatumumab |
| 2 | Experimental | FOLFOX 4 followed by Adecatumumab Receives: Drug: Adecatumumab and FOLFOX |
| 3 | Active comparator | FOLFOX 4 alone Receives: Drug: FOLFOX 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival rate (DFS)
Measured: 1 year
Secondary outcomes (3)
time to relapse
Measured: 1 year
Incidence of AEs
Measured: 1 year
Quality of Life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen Research (Munich) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Neuhaus, Prof. Dr., Principal investigator, Charité Campus Virchow Klinikum, BerlinPatrick Dufour, Pr. Dr., Principal investigator, Centre Paul Strauss, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866944
- Sponsor's protocol ID
- MT201-204
- Acronym
- MT201-204
- Status last verified
- Nov 2011
- First submitted
- 20 Mar 2009
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT00866944
- Acronym / sponsor ID
- MT201-204 / MT201-204
- Conditions
- Liver Metastases, Colorectal Cancer
- Keywords
- Colorectal carcinoma, Liver metastases (only), R0 resection, R0 resection of liver metastases from colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Amgen Research (Munich) GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Mar 2009 (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 this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AdecatumumabAdecatumumab alone |
| 2 | Experimental | Drug: Adecatumumab and FOLFOXFOLFOX 4 followed by Adecatumumab |
| 3 | Active comparator | Drug: FOLFOX 4FOLFOX 4 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma
- Age ≥18 years
- ECOG performance status ≤ 2
- Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent
Key exclusion criteria (21 listed)
- Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
- Neoadjuvant chemotherapy of liver metastases prior to surgery
- Any anticancer chemotherapy within 4 weeks prior to study entry
- Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
- Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
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 |
|---|---|---|
| AdecatumumabAlso: MT201Adecatumumab,6-9mg/kg, every 14 days, 24 cycles | Drug | 1 |
| Adecatumumab and FOLFOXFOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles | Drug | 2 |
| FOLFOX 4FOLFOX 4, every 14 days, 12 cycles | Drug | 3 |
Primary outcome
Disease free survival rate (DFS)
Time frame: 1 year
3 secondary outcomes
time to relapse
Time frame: 1 year
Incidence of AEs
Time frame: 1 year
Quality of Life
Time frame: 1 year
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 11 Nov 2011.
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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.
Peter Neuhaus, Prof. Dr. principal investigator
Charité Campus Virchow Klinikum, Berlin
Patrick Dufour, Pr. Dr. principal investigator
Centre Paul Strauss, Strasbourg
16 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 Adecatumumab, Adecatumumab and FOLFOX and FOLFOX 4 in people with Liver Metastases and Colorectal Cancer, run by Amgen Research (Munich) GmbH at 16 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 21 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, France. 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 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?
Disease free survival rate (DFS) (time frame: 1 year). 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 11 Nov 2011.