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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Breast Cancer MM302 Locally advanced/unresectable metastatic Breast Neoplasms Cyclophosphamide Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merrimack Pharmaceuticals
ID
NCT01304797
Phase
Phase 1
Study Type
Interventional
Last Updated
January 4, 2017