A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers



Status:Completed
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2010
End Date:July 2014

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A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

This study is a Phase 1 and pharmacologic open-labeled 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 to
explore pharmacodynamic endpoints.


Inclusion Criteria:

- Cytological or histological confirmation of locally advanced/metastatic or recurrent
epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or
endometrial cancer; OR, cytological or histological confirmation of locally advanced
/metastatic Her2 non-overexpressing breast cancer

- Eighteen years of age or above

- Candidates for chemotherapy

- 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 (PS) of ≤ 2

- 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-121

Exclusion Criteria:

- Prior radiation therapy to >25% of bone marrow-bearing areas

- Evidence of any other active malignancy

- 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-121 or who have had
hypersensitivity reactions to fully human monoclonal antibodies

- Received treatment, within 30 days prior to the first scheduled day of dosing, with
any investigational agents that have not received regulatory approval for any
indication or disease state

- Pregnant or breast feeding
We found this trial at
3
sites
Boston, Massachusetts 02115
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Boston, MA
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Bakersfield, California 93309
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Bakersfield, CA
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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