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
1 other identifier
interventional
75
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Mar 2011
Typical duration for phase_1 breast-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 6, 2017
January 1, 2017
5.4 years
February 24, 2011
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The severity and the number of adverse events related to escalating doses of the MM-302.
12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
12 months
Secondary Outcomes (3)
Objective response rate of MM-302
12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
12 months
Study Arms (4)
MM-302
EXPERIMENTALMM-302 in Combination with Trastuzumab
EXPERIMENTALMM-302 in Combination with Trastuzumab q3w
EXPERIMENTALMM-302 in Combination with Trastuzumab and Cyclophosphamide
EXPERIMENTALInterventions
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
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
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California San Francisco
San Francisco, California, United States
University of Indiana
Indianapolis, Indiana, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Related Publications (1)
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.
PMID: 28298546DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2016
Study Completion
January 1, 2017
Last Updated
January 6, 2017
Record last verified: 2017-01