Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | September 2016 |
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
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.
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.
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
We found this trial at
5
sites
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