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

Phase 1

• Conditions: Breast Cancer
• Interventions: 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

• Registration Number: NCT01304797
• Lead Sponsor: Merrimack Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Study Start: 2011-03
• Primary Completion: 2016-08
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MM-302	MM-302 Monotherapy	-
MM-302 in Combination with Trastuzumab	MM-302 in combination with trastuzumab	-
MM-302 in Combination with Trastuzumab q3w	MM-302 in combination with trastuzumab q3w	-
MM-302 in Combination with Trastuzumab and Cyclophosphamide	MM-302 in combination with trastuzumab and cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Objective response rate of MM-302	12 months

Trial Locations

Locations (5)

Dana Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

University of Indiana; 🇺🇸 Indianapolis, Indiana, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States