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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01304797
Recruitment Status : Unknown
Verified January 2017 by Merrimack Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. The severity and the number of adverse events related to escalating doses of the MM-302. [ Time Frame: 12 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. Objective response rate of MM-302 [ Time Frame: 12 months ]
  2. The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax [ Time Frame: 12 months ]
  3. Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304797


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States
United States, Indiana
University of Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Dana Farber Cancer Center
Boston, Massachusetts, United States
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States
Sponsors and Collaborators
Merrimack Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01304797    
Other Study ID Numbers: MM-302-02-01-01
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Keywords provided by Merrimack Pharmaceuticals:
MM302
Breast Cancer
Locally advanced/unresectable
metastatic
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Doxorubicin
Gancotamab
Immunoconjugates
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors