Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments mm-302 monotherapy, mm-302 in combination with trastuzumab, mm-302 in combination with trastuzumab q3w, mm-302 in combination with trastuzumab and cyclophosphamide
Phase phase 1
Sponsor Merrimack Pharmaceuticals
Start date March 2011
End date May 2016
Trial size 75 participants
Trial identifier NCT01304797, MM-302-02-01-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mm-302 monotherapy
Escalating doses of MM-302 as a single agent
(Experimental)
mm-302 in combination with trastuzumab Herceptin
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
(Experimental)
mm-302 in combination with trastuzumab q3w herceptin
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
(Experimental)
mm-302 in combination with trastuzumab and cyclophosphamide herceptin
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 Outcomes

Measure
The severity and the number of adverse events related to escalating doses of the MM-302.
time frame: 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
time frame: 12 months

Secondary Outcomes

Measure
Objective response rate of MM-302
time frame: 12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
time frame: 12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Merrimack Pharmaceuticals.