A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
Completed · Phase 1
Conditions studied: Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,, Primary Peritoneal Cancer or Endometrial Cancer, Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
In brief
This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.
Key facts
- Study ID
- NCT01209195
- Run by
- Merrimack Pharmaceuticals
- People needed
- 41
- Starts
- 2010-10-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2016-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
- Comprehensive Blood and Cancer Center — Bakersfield, California, United States
- Cancer Care Associates of Fresno — Fresno, California, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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