Status:
COMPLETED
A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
Lead Sponsor:
Merrimack Pharmaceuticals
Conditions:
Her2 Amplified Solid Tumors
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is an open-label Phase 1 trial of MM-111.
Detailed Description
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00911898
Start Date
June 1 2009
End Date
March 1 2012
Last Update
January 13 2015
Active Locations (4)
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1
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Indiana University (IUPUI)
Indianapolis, Indiana, United States, 46268
3
Fox Chase Center
Philadelphia, Pennsylvania, United States, 19111
4
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229