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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097460
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : December 4, 2014
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: MM-111 + Herceptin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: MM-111 + Herceptin
MM-111 will be combined with Herceptin
Drug: MM-111 + Herceptin
For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
Other Name: Trastuzumab

Primary Outcome Measures :
  1. Incidence of Treatment-emergent AE's [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01097460

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United States, Indiana
Indiana University (IUPUI)
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Merrimack Pharmaceuticals
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Principal Investigator: Michaela Higgins, MD Massachusetts General Hospital
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Responsible Party: Merrimack Pharmaceuticals Identifier: NCT01097460    
Other Study ID Numbers: MM-111-02-12-02
First Posted: April 1, 2010    Key Record Dates
Results First Posted: December 4, 2014
Last Update Posted: January 7, 2015
Last Verified: December 2014
Keywords provided by Merrimack Pharmaceuticals:
Bispecific Antibody
Breast Cancer
Advanced Breast Cancer
Metastatic Breast Cancer
HER2 Positive Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents