Breast NeoplasmsPhase 1NCT01097460

MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

A Phase 1 study testing MM-111 + Herceptin in people with Breast Neoplasms, run by Merrimack Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Neoplasms
What is being tested?: MM-111 + Herceptin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 3 sitesUnited States
Study dates: Apr 2010to Jul 2013
Phase: Phase 1
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 histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)
Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy
The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes
Patients must be ≥ 18 years of age
Patients or their legal representatives must be able to understand and sign an informed consent
Patients may have measurable (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1)

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Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).
Patients should have a life expectancy of at least 12 weeks
Patients must have adequate bone marrow reserves
Patients must have adequate hepatic function
Patients must have adequate renal function
Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy.
Women of childbearing potential as well as fertile men and their partners must agree 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-111.

Who cannot join

Patients who are pregnant or lactating
Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing.
Patients with untreated and/or symptomatic metastatic CNS malignancies.
Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.
Patients who have received other recent antitumor therapy including:
Treatment with Herceptin within the 28 days prior to the first scheduled day of dosing with MM-111

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Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.)
Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111
Patients who have previously received MM-111
Patients with NYHA Class III or IV congestive heart failure or LVEF < 50%
Patients with a history of allogeneic transplant
Patients with known HIV, hepatitis B or C (if patients have previously been treated for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial)
Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Indiana University (IUPUI)
Indianapolis, Indiana, 46202
Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Read the detailed description

Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.

Conditions: Breast Neoplasms
Being tested: MM-111 + Herceptin
Keywords: HER2/HER3, Bispecific Antibody, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive Breast Cancer, Trastuzumab, Herceptin
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MM-111 + HerceptinDrug
Also called Trastuzumab
For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV

Study groups in NCT01097460
Study group	Role	What they receive
MM-111 + Herceptin	Experimental	MM-111 will be combined with Herceptin Receives: Drug: MM-111 + Herceptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-emergent AE's
Measured: 2 years

Secondary outcomes (1)

To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jul 2013

First posted1 Apr 2010 (estimated)
Study startApr 2010
Primary completionJul 2013
Study completionJul 2013

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 Breast NeoplasmsStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01097460
Sponsor's protocol ID: MM-111-02-12-02
Status last verified: Dec 2014
First submitted: 30 Mar 2010
Last updated: 7 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer
ClinicalTrials.gov ID: NCT01097460
Acronym / sponsor ID: MM-111-02-12-02
Conditions: Breast Neoplasms
Keywords: HER2/HER3, Bispecific Antibody, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive Breast Cancer, Trastuzumab, Herceptin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 1 Apr 2010 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Detailed description

Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MM-111 + Herceptin	Experimental	Drug: MM-111 + HerceptinMM-111 will be combined with Herceptin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)
Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy
The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes
Patients must be ≥ 18 years of age
Patients or their legal representatives must be able to understand and sign an informed consent

Key exclusion criteria (13 listed)

Patients who are pregnant or lactating
Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F) during screening visits or on the first scheduled day of dosing.
Patients with untreated and/or symptomatic metastatic CNS malignancies.
Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.
Patients who have received other recent antitumor therapy including:

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-111 + HerceptinAlso: TrastuzumabFor Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV	Drug	MM-111 + Herceptin

Primary outcome

Incidence of Treatment-emergent AE's
Time frame: 2 years

1 secondary outcome

To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination
Time frame: 2 years

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MM-111 + Herceptin	16	16

Primary outcome: Incidence of Treatment-emergent AE's

Time frame: 2 years. Number. Unit: participants

Measure	MM-111 + Herceptin n = 16
Value	16

Population analysed: Patients that received at least one dose

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MM-111 + Herceptin	2 of 16 (12.5%)	16 of 16 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Michaela Higgins, MD principal investigator

Massachusetts General Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MM-111 + Herceptin in people with Breast Neoplasms, run by Merrimack Pharmaceuticals at 3 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 13 inclusion and 13 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

Yes. Results are posted in the registry (first posted 4 Dec 2014). 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?

Incidence of Treatment-emergent AE's (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01097460.

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 7 Jan 2015.