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

This study is currently recruiting participants.
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: February 25, 2014
Last verified: February 2014

February 24, 2011
February 25, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01304797 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: MM-302 Monotherapy
    Escalating doses of MM-302 as a single agent
  • 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
  • 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
  • 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
  • Experimental: MM-302
    Intervention: Drug: MM-302 Monotherapy
  • Experimental: MM-302 in Combination with Trastuzumab
    Intervention: Drug: MM-302 in combination with trastuzumab
  • Experimental: MM-302 in Combination with Trastuzumab q3w
    Intervention: Drug: MM-302 in combination with trastuzumab q3w
  • Experimental: MM-302 in Combination with Trastuzumab and Cyclophosphamide
    Intervention: Drug: MM-302 in combination with trastuzumab and cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
April 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Victor Moyo, MD 617-441-1007
United States
 
NCT01304797
MM-302-02-01-01
No
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Not Provided
Merrimack Pharmaceuticals
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP