Title A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Dacarbazine in Subjects with Soft Tissue Sarcoma
Contact KH
Principal Investigator Nikhil Khushalani, MD
Study Number 195811
Phase3
Summary
This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of Eribulin with Dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrollment following standard therapies with must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.
Eligibility
Inclusion:
- Histologically confirmed diagnosis of soft tissue sarcoma of high or intermediated grade with one of the following histological subtypes:
- Adipocytic Sacroma, including: Dedifferentiated, Myxoid, round cell, Pleomorphic, Leiomyosarcoma
- Documented evidence of advanced (locally recurrent, locally advanced and/or metastatic) adipocytic (restricted to subtypes listed in Inclusion 1) or Leiomyosarcoma, incurable by surgery and/or radiotherapy
- Subjects should have received standard therapies for advanced soft tissue sarcoma which must have included an anthracycline (unless contraindicated) with or without ifosfamide and then at least one additional regimen after failure of the anthracycline
- Radiographic evidence of disease progression by RECIST criteria on or after the last anti-cancer therapy within the 6 months prior to randomization
Exclusion:
- Subjects who have received any anti-cancer therapy, including radiotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or any investigational agent within 30 days, prior to randomization
- Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to < Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy and alopecia
- Subjects that have previously been treated with Dacarbazine or participated in a study with Eribulin (whether treated with Eribulin or not)
- Radiation therapy encompassing > 30% of bone marrow