Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Condition: Metastatic Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: MORAb-004; Gemcitabine; Docetaxel; Gemcitabine; Docetaxel; Placebo
Intervention description: IV, Days 1 and 8 of every cycle until disease progression; IV, Days 1 and 8 of each cycle until disease progression; IV, Day 8 of every cycle until disease progression; IV, Days 1 and 8 of each cycle until disease progression; IV, Day 8 of every cycle until disease progression
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to see if MORAb-004 increases the effectiveness of the
      chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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