Status:
TERMINATED
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Halozyme Therapeutics
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombina...
Detailed Description
Phase 1b will occur in two parts: Part 1: Run-in safety cohort(s) (dose levels 1, 0, and -1, as necessary) of 6 participants each will be conducted until the RP2D is determined. The purpose of the ru...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Metastatic Her-2- breast cancer
- Up to 2 prior lines of cytotoxic or targeted anti-cancer therapy for metastatic disease
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Exclusion Criteria
- Less than 6 months since prior neoadjuvant/adjuvant chemotherapy
- Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
- Previous history or current evidence of deep vein thrombosis (DVT), hereditary thrombophilic syndromes, pulmonary embolism (PE), cerebral vascular accident (CVA), transient ischemic attack (TIA), atrial fibrillation (AF), or active carotid artery disease requiring treatment
- Treatment with chemotherapy, hormonal, or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks preceding informed consent
- Pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
July 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02753595
Start Date
July 13 2016
End Date
August 16 2019
Last Update
July 13 2020
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Whittier, California, United States, 90602
2
Atlanta, Georgia, United States, 30318
3
Newnan, Georgia, United States, 30265
4
Anderson, Indiana, United States, 46011