Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MM-302 Monotherapy
MM-302 in combination with trastuzumab
MM-302 in combination with trastuzumab q3w
MM-302 in combination with trastuzumab and cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring MM302, Breast Cancer, Locally advanced/unresectable, metastatic
Eligibility 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
Sites / Locations
- University of California San Francisco
- University of Indiana
- Dana Farber Cancer Center
- Karmanos Cancer Center
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
MM-302
MM-302 in Combination with Trastuzumab
MM-302 in Combination with Trastuzumab q3w
MM-302 in Combination with Trastuzumab and Cyclophosphamide
Arm Description
Outcomes
Primary Outcome Measures
The severity and the number of adverse events related to escalating doses of the MM-302.
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
Secondary Outcome Measures
Objective response rate of MM-302
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Full Information
NCT ID
NCT01304797
First Posted
February 24, 2011
Last Updated
January 4, 2017
Sponsor
Merrimack Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01304797
Brief Title
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
MM302, Breast Cancer, Locally advanced/unresectable, metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MM-302
Arm Type
Experimental
Arm Title
MM-302 in Combination with Trastuzumab
Arm Type
Experimental
Arm Title
MM-302 in Combination with Trastuzumab q3w
Arm Type
Experimental
Arm Title
MM-302 in Combination with Trastuzumab and Cyclophosphamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MM-302 Monotherapy
Intervention Description
Escalating doses of MM-302 as a single agent
Intervention Type
Drug
Intervention Name(s)
MM-302 in combination with trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
Intervention Type
Drug
Intervention Name(s)
MM-302 in combination with trastuzumab q3w
Other Intervention Name(s)
herceptin
Intervention Description
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
Intervention Type
Drug
Intervention Name(s)
MM-302 in combination with trastuzumab and cyclophosphamide
Other Intervention Name(s)
herceptin, cytoxan; neosar
Intervention Description
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
Primary Outcome Measure Information:
Title
The severity and the number of adverse events related to escalating doses of the MM-302.
Time Frame
12 months
Title
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 Measure Information:
Title
Objective response rate of MM-302
Time Frame
12 months
Title
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Time Frame
12 months
Title
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Indiana
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Dana Farber Cancer Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28298546
Citation
Lee H, Shields AF, Siegel BA, Miller KD, Krop I, Ma CX, LoRusso PM, Munster PN, Campbell K, Gaddy DF, Leonard SC, Geretti E, Blocker SJ, Kirpotin DB, Moyo V, Wickham TJ, Hendriks BS. 64Cu-MM-302 Positron Emission Tomography Quantifies Variability of Enhanced Permeability and Retention of Nanoparticles in Relation to Treatment Response in Patients with Metastatic Breast Cancer. Clin Cancer Res. 2017 Aug 1;23(15):4190-4202. doi: 10.1158/1078-0432.CCR-16-3193. Epub 2017 Mar 15.
Results Reference
derived
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Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
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