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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:
ClinicalTrials.gov Identifier:
NCT00911898
First Posted: June 3, 2009
Last Update Posted: January 13, 2015
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.
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
  • To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity [ Time Frame: December 2011 ]

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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00911898     History of Changes
Other Study ID Numbers: MM-111-01-100
First Submitted: June 2, 2009
First Posted: June 3, 2009
Results First Submitted: February 28, 2014
Results First Posted: September 15, 2014
Last Update Posted: January 13, 2015
Last Verified: December 2014

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