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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01304797
First received: February 24, 2011
Last updated: June 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: MM-302 Monotherapy
Drug: MM-302 in combination with trastuzumab
Drug: MM-302 in combination with trastuzumab q3w
Drug: MM-302 in combination with trastuzumab and cyclophosphamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • The severity and the number of adverse events related to escalating doses of the MM-302. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate of MM-302 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304797

Contacts
Contact: Victor Moyo, MD 617-441-1094

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States
United States, Indiana
University of Indiana Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States
United States, Michigan
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01304797     History of Changes
Other Study ID Numbers: MM-302-02-01-01
Study First Received: February 24, 2011
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
MM302
Breast Cancer
Locally advanced/unresectable
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 28, 2014