Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

Completed · Phase 2 · Has a placebo group

Conditions studied: Metastatic Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT01574716

Run by

Morphotek

People needed

209

Starts

2012-08-07

Expected to finish

2016-08-02

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• UCLA — Santa Monica, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Siouxland Hematology-Oncology — Sioux City, Iowa, United States
• Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mayo Clinic - Rochester — Rochester, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States
• Seattle Care Alliance — Seattle, Washington, United States
• Canberra Hospital — Garran, Australian Capital Territory, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Ashford Cancer Centre Research — Kurralta Park, South Australia, Australia
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
• UZ Leuven Medical Oncology — Leuven, Belgium

Full record on ClinicalTrials.gov

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