Status:
COMPLETED
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
Lead Sponsor:
Merrimack Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,
Primary Peritoneal Cancer or Endometrial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01209195
Start Date
October 1 2010
End Date
July 1 2014
Last Update
September 8 2016
Active Locations (5)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
3
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
4
Cancer Care Associates of Fresno
Fresno, California, United States, 93720