Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
- Conditions
- Metastatic Soft Tissue Sarcoma
- Interventions
- Registration Number
- NCT01574716
- Lead Sponsor
- Morphotek
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo, gemcitabine, docetaxel Placebo - MORAb-004, gemcitabine, docetaxel MORAb-004 - Placebo, gemcitabine, docetaxel Gemcitabine - MORAb-004, gemcitabine, docetaxel Gemcitabine - MORAb-004, gemcitabine, docetaxel Docetaxel - Placebo, gemcitabine, docetaxel Docetaxel -
- Primary Outcome Measures
Name Time Method Part 2: Radiologic Progression-free Survival (PFS) From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years) PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
- Secondary Outcome Measures
Name Time Method Part 2: Overall Response Rate (ORR) From date of first dose until disease progression (up to approximately 3.5 years) ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Part 2: Symptomatic Progression-free Survival From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years) PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
Part 2: Radiologic Progression-free Survival Rate (PFR) Weeks 12, 24, 48 and 52 Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels Up to approximately 3 years Part 2: Overall Survival (OS) From date of first dose until date of death from any cause (up to approximately 3.5 years) OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
Trial Locations
- Locations (29)
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Mayo Clinic - Rochester
🇺🇸Rochester, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Institut Gustave Roussy
🇫🇷Villejuif, France
UZ Leuven Medical Oncology
🇧🇪Leuven, Belgium
Seattle Care Alliance
🇺🇸Seattle, Washington, United States
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
University of Claude Bernard
🇫🇷Villeurbanne, France
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
UCLA
🇺🇸Santa Monica, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Huntsman Cancer Institute at the University of Utah
🇺🇸Salt Lake City, Utah, United States
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research
🇦🇺Kurralta Park, South Australia, Australia