Hepatocellular CarcinomaPhase 1NCT01733004
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
A Phase 1 study testing MM-141 in people with Hepatocellular Carcinoma, run by Merrimack Pharmaceuticals at 4 sites in 2 countries.
Trial summary
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MM-141
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2012to Jan 2016
- Phase
- Phase 1
- 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
- Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
- Adequate bone marrow, hepatic, renal and cardiac function
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
Who cannot join
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Received other recent antitumor therapy
- Pregnant or breast feeding
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Study site
Boston, Massachusetts
Study site
Detroit, Michigan
Study site
Marietta, Georgia
About this study
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MM-141
- Keywords
- Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Insulin-Like Growth Factor I, Resistance To
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-141Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | MM-141 monotherapy Receives: Drug: MM-141 |
| Arm B | Experimental | MM-141 and Everolimus Receives: Drug: MM-141 |
| Arm C | Experimental | MM-141 and Abraxane and Gemcitabine Receives: Drug: MM-141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and number of adverse events related to escalating doses of MM-141
Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chrystal Louis, MD, MPH, Study director, Merrimack Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733004
- Sponsor's protocol ID
- MM-141-01-01-01
- Status last verified
- Aug 2016
- First submitted
- 20 Nov 2012
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01733004
- Acronym / sponsor ID
- MM-141-01-01-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (actual)
- First posted
- 26 Nov 2012 (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.
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: MM-141MM-141 monotherapy |
| Arm B | Experimental | Drug: MM-141MM-141 and Everolimus |
| Arm C | Experimental | Drug: MM-141MM-141 and Abraxane and Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
Key exclusion criteria (4 listed)
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Received other recent antitumor therapy
- Pregnant or breast feeding
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 |
|---|---|---|
| MM-141 | Drug | Arm A, Arm B, Arm C |
Primary outcome
Severity and number of adverse events related to escalating doses of MM-141
Time frame: 2 years
Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
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 4 Aug 2016.
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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.
Chrystal Louis, MD, MPH study director
Merrimack Pharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MM-141 in people with Hepatocellular Carcinoma, run by Merrimack Pharmaceuticals at 4 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 7 inclusion and 4 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 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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 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.
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?
Severity and number of adverse events related to escalating doses of MM-141 (time frame: 2 years). 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 4 Aug 2016.