Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

January 4, 2017 updated by: Merrimack Pharmaceuticals

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • University of California San Francisco
    • Indiana
      • Indianapolis, Indiana, United States
        • University of Indiana
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Center
    • Michigan
      • Detroit, Michigan, United States
        • Karmanos Cancer Center
    • Missouri
      • St. Louis, Missouri, United States
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Locally advanced/unresectable or metastatic breast cancer
  • Eighteen years of age or above
  • Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  • Measurable disease according to RECIST v1.1
  • ECOG Performance Score of 0 or 1
  • Adequate bone marrow, hepatic, renal and cardiac function
  • Willing 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-302

Exclusion Criteria:

  • Patients for whom potentially curative anticancer therapy is available
  • Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
  • Symptomatic CNS disease
  • Known hypersensitivity to any of the components of MM-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
  • Received other recent antitumor therapy
  • Pregnant or breast feeding
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MM-302
Drug: MM-302 Monotherapy
Escalating doses of MM-302 as a single agent
EXPERIMENTAL: MM-302 in Combination with Trastuzumab
Drug: MM-302 in combination with trastuzumab
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
Other Names:
  • Herceptin
EXPERIMENTAL: MM-302 in Combination with Trastuzumab q3w
Drug: MM-302 in combination with trastuzumab q3w
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
Other Names:
  • herceptin
EXPERIMENTAL: MM-302 in Combination with Trastuzumab and Cyclophosphamide
Drug: MM-302 in combination with trastuzumab and cyclophosphamide
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule
Other Names:
  • herceptin
  • cytoxan; neosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The severity and the number of adverse events related to escalating doses of the MM-302.
Time Frame: 12 months
12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate of MM-302
Time Frame: 12 months
12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Time Frame: 12 months
12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merrimack Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (ESTIMATE)

February 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-302-02-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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