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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Merrimack Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01097460
First received: March 30, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
HER2 Amplified Breast Cancer
Metastatic or Advanced Breast Cancer
Drug: MM-111 and Herceptin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • To assess the safety of MM-111 + Herceptin in combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the recommended Phase 2 doses of MM-111 + Herceptin in combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-111 + Herceptin
MM-111 will be combined with Herceptin
Drug: MM-111 and Herceptin
For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
Other Name: Trastuzumab

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097460

Locations
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
Investigators
Principal Investigator: Michaela Higgins, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01097460     History of Changes
Other Study ID Numbers: MM-111-02-12-02
Study First Received: March 30, 2010
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
HER2/HER3
Bispecific Antibody
Breast Cancer
Advanced Breast Cancer
Metastatic Breast Cancer
HER2 Positive Breast Cancer
Trastuzumab
Herceptin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014