HER-2 Gene AmplificationPhase 2NCT01774851
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
A Phase 2 study testing MM-111, Paclitaxel and Trastuzumab in people with HER-2 Gene Amplification and Esophagus Cancer, run by Merrimack Pharmaceuticals at 21 sites in United States.
Trial summary
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- MM-111, Paclitaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
- Patients must have documentation of histologically or cytologically confirmed HER2 expression
- Patients must be ≥18 years of age
- Patients must have ECOG PS of 0, 1, or 2
- Patients must have adequate hematologic status, renal and hepatic function
Who cannot join
- Patients with known hypersensitivity to any of the components of MM-111
- Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL
- Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)
- Patients with an active infection or with an unexplained fever >38.5°C
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02114
Study site
Buffalo, New York, 14263
Study site
Cleveland, Ohio, 44106
Study site
Columbus, Ohio, 43210
Study site
Denver, Colorado, 80218
Study site
Durham, North Carolina, 27710
Study site
Las Vegas, Nevada, 89135
Study site
Los Angeles, California, 90089
Study site
Los Angeles, California, 90095
Study site
Nashville, Tennessee, 37203
Study site
Ocala, Florida, 34471
Study site
Philadelphia, Pennsylvania, 19111
Study site
Pittsburgh, Pennsylvania, 15232
Study site
Rochester, Minnesota, 55905
Study site
St Louis, Missouri, 63110
Study site
St. Petersburg, Florida, 33705
Study site
Stanford, California, 94305
Study site
Urbana, Illinois, 61801
Study site
Wenatchee, Washington, 98801
About this study
Official title: Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Read the detailed description
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.
- Conditions
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer
- Being tested
- MM-111, Paclitaxel, Trastuzumab
- Keywords
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-111Drug
MM-111 (IV)
PaclitaxelDrug
Paclitaxel (IV)
TrastuzumabDrug
Trastuzumab (IV)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1a | Experimental | MM-111 + Paclitaxel + Trastuzumab Receives: Drug: MM-111; Drug: Paclitaxel; Drug: Trastuzumab |
| Arm 1b | Active comparator | Paclitaxel + Trastuzumab Receives: Drug: Paclitaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionDec 2015
Why it stopped: DSMB recommendation due to lack of efficacy. There were no safety signals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER-2 Gene AmplificationStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akos Czibere, MD, PhD, Study director, Merrimack Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774851
- Sponsor's protocol ID
- MM-111-13-02-04
- Status last verified
- Jun 2017
- First submitted
- 10 Jan 2013
- Last updated
- 22 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
- ClinicalTrials.gov ID
- NCT01774851
- Acronym / sponsor ID
- MM-111-13-02-04
- Conditions
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer
- Keywords
- HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation due to lack of efficacy. There were no safety signals.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 22 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Detailed description
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1a | Experimental | Drug: MM-111, Drug: Paclitaxel, Drug: TrastuzumabMM-111 + Paclitaxel + Trastuzumab |
| Arm 1b | Active comparator | Drug: Paclitaxel, Drug: TrastuzumabPaclitaxel + Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
- Patients must have documentation of histologically or cytologically confirmed HER2 expression
- Patients must be ≥18 years of age
- Patients must have ECOG PS of 0, 1, or 2
- Patients must have adequate hematologic status, renal and hepatic function
Key exclusion criteria (4 listed)
- Patients with known hypersensitivity to any of the components of MM-111
- Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL
- Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)
- Patients with an active infection or with an unexplained fever >38.5°C
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-111MM-111 (IV) | Drug | Arm 1a |
| PaclitaxelPaclitaxel (IV) | Drug | Arm 1a, Arm 1b |
| TrastuzumabTrastuzumab (IV) | Drug | Arm 1a, Arm 1b |
Primary outcome
Progression Free Survival (PFS)
Time frame: 30 months
Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Akos Czibere, MD, PhD study director
Merrimack Pharmaceuticals
21 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 MM-111, Paclitaxel and Trastuzumab in people with HER-2 Gene Amplification and Esophagus Cancer, run by Merrimack Pharmaceuticals at 21 sites in United States.
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 5 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: stopped early, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: 30 months). 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 22 Jun 2017.