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

Metastatic Breast Cancer Clinical Trial

— Monotherapy  

Official title:

A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911898
• Other study ID #: MM-111-01-100
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2009
• Last updated: December 30, 2014
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Her2 Amplified Solid Tumors
• Metastatic Breast Cancer

Intervention

Drug:
• MM-111
For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV

Locations

Country	Name	City	State
United States	Indiana University (IUPUI)	Indianapolis	Indiana
United States	University of Southern California Norris Comprehensive Cancer Center	Los Angeles	California
United States	Fox Chase Center	Philadelphia	Pennsylvania
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) or Maximum Feasible Dose	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.	28 days	Yes
Secondary	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)		December 2011	No
Secondary	To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity		December 2011	No