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

NCT ID: NCT00911898

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-03-31

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.

Conditions

Her2 Amplified Solid Tumors; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MM-111

Group Type: EXPERIMENTAL

MM-111

Intervention Type: DRUG

For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV

Interventions

MM-111

For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merrimack Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muralidhar Beeram, MD

Role: PRINCIPAL_INVESTIGATOR

The START Center for Cancer Care

Locations

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, United States

Indiana University (IUPUI)

Indianapolis, Indiana, United States

Fox Chase Center

Philadelphia, Pennsylvania, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Countries

United States

Other Identifiers

MM-111-01-100

Identifier Type: -

Identifier Source: org_study_id