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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merrimack Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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