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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MM-302

Group Type EXPERIMENTAL

MM-302 Monotherapy

Intervention Type DRUG

Escalating doses of MM-302 as a single agent

MM-302 in Combination with Trastuzumab

Group Type EXPERIMENTAL

MM-302 in combination with trastuzumab

Intervention Type DRUG

Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule

MM-302 in Combination with Trastuzumab q3w

Group Type EXPERIMENTAL

MM-302 in combination with trastuzumab q3w

Intervention Type DRUG

Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule

MM-302 in Combination with Trastuzumab and Cyclophosphamide

Group Type EXPERIMENTAL

MM-302 in combination with trastuzumab and cyclophosphamide

Intervention Type DRUG

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

Interventions

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MM-302 Monotherapy

Escalating doses of MM-302 as a single agent

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Herceptin herceptin herceptin cytoxan; neosar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No