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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
209
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
Part 2: Radiologic Progression-free Survival (PFS)
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.
Time frame: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
Part 2: Symptomatic Progression-free Survival
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.
Time frame: 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)
Part 2: Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
Time frame: From date of first dose until date of death from any cause (up to approximately 3.5 years)
Part 2: Overall Response Rate (ORR)
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.
Time frame: From date of first dose until disease progression (up to approximately 3.5 years)
Part 2: Radiologic Progression-free Survival Rate (PFR)
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IV, Days 1 and 8 of each cycle until disease progression
IV, Day 8 of every cycle until disease progression
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
...and 19 more locations
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
Time frame: Weeks 12, 24, 48 and 52
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Time frame: Up to approximately 3 years