Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Morphotek
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be at least 18 years of age
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
Have tumor tissue available for TEM-1 biomarker studies
Be willing and able to provide written informed consent
You may not be if
Have received more than 2 prior systemic treatment regimens for mSTS
Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
Have a diagnosis of primary bone sarcoma of any histological type.
Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
Have a history of allergic reaction to prior monoclonal antibody or biologic agent
Have received previous treatment with MORAb-004 (anti-TEM-1)
Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
