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A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers (Monotherapy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00911898
First received: June 2, 2009
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

This study is an open-label Phase 1 trial of MM-111.


Condition Intervention Phase
Her2 Amplified Solid Tumors
Metastatic Breast Cancer
Drug: MM-111
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) or Maximum Feasible Dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.


Secondary Outcome Measures:
  • To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR) [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
  • To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity [ Time Frame: December 2011 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-111 Drug: MM-111
For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV

Detailed Description:

Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.

  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 cancer that is:

    • HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation
    • Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory
  • Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
  • Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
  • 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 or non-measurable tumor(s)
  • Patients should have ECOG Performance Score (PS) 0 or 1
  • Patients must have adequate bone marrow reserves as evidenced by:

    • Absolute neutrophil count (ANC) >= 1,500/uL and
    • Platelet count >= 100,000/uL
    • Hemoglobin >= 9 g/dL
  • Patients must have tumor tissue amenable to biopsy
  • Patients must be willing to undergo biopsy prior to treatment to MM-111

Exclusion Criteria:

  • Patients for whom potentially curative antineoplastic therapy is available
  • Patients who are pregnant or lactating
  • Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)
  • Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
  • Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
  • Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
  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: NCT00911898

Locations
United States, California
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Indiana
Indiana University (IUPUI)
Indianapolis, Indiana, United States, 46268
United States, Pennsylvania
Fox Chase Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Principal Investigator: Muralidhar Beeram, MD The START Center for Cancer Care
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00911898     History of Changes
Other Study ID Numbers: MM-111-01-100
Study First Received: June 2, 2009
Results First Received: February 28, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Her2 amplified solid tumors
Breast Cancer
Her3/ErbB3
Bispecific Antibody

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014