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MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer

Information source: Merrimack Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: MM-111 + Herceptin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merrimack Pharmaceuticals

Official(s) and/or principal investigator(s):
Michaela Higgins, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Summary

This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Clinical Details

Official title: MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer

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

Primary outcome: Incidence of Treatment-emergent AE's

Secondary outcome: To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination

Detailed description: Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced breast cancer

that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)

- Patients must have histologically or cytologically confirmed advanced breast cancer

that is heregulin positive based on fresh tumor tissue biopsy

- The patient's cancer must have recurred, progressed or not responded to standard

chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes

- 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 (per RECIST 1. 1) or non-measurable tumor(s) (for Phase

1)

- Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).

- Patients should have a life expectancy of at least 12 weeks

- Patients must have adequate bone marrow reserves

- Patients must have adequate hepatic function

- Patients must have adequate renal function

- Patients must be recovered from the effects of any prior surgery, radiotherapy or

other antineoplastic therapy.

- Women of childbearing potential as well as fertile men and their partners must agree

to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-111. Exclusion Criteria:

- Patients who are pregnant or lactating

- Patients with an active infection or with an unexplained fever > 38. 5°C (101. 3° F)

during screening visits or on the first scheduled day of dosing.

- Patients with untreated and/or symptomatic metastatic CNS malignancies.

- Patients with known hypersensitivity to any of the components of MM-111 or who have

had hypersensitivity reactions to fully human monoclonal antibodies, including Herceptin.

- Patients who have received other recent antitumor therapy including:

- Treatment with Herceptin within the 28 days prior to the first scheduled day of

dosing with MM-111

- Investigational therapy administered within the 28 days prior to the first

scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed.)

- Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and

having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of MM-111

- Patients who have previously received MM-111

- Patients with NYHA Class III or IV congestive heart failure or LVEF < 50%

- Patients with a history of allogeneic transplant

- Patients with known HIV, hepatitis B or C (if patients have previously been treated

for hepatitis C and have undetectable viral loads, they can be considered eligible for the trial)

- Patients with any other medical or psychological condition deemed by the Investigator

to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Locations and Contacts

Indiana University (IUPUI), Indianapolis, Indiana 46202, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States

Additional Information

Starting date: April 2010
Last updated: December 18, 2014

Page last updated: August 23, 2015

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