The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
USC/Norris Comp Cancer Center
Los Angeles, California, United States
Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood
Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.
Time frame: Baseline, End of Cycle 1 (21 days)
Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue
Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.
Time frame: Baseline, End of Cycle 1 (21 days)
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.
Time frame: Baseline, End of Cycle 1 (21 days)
Progression Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.
Time frame: Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)
Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)
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Yale University School of Medicine
New Haven, Connecticut, United States
All Children's Hospital
St. Petersburg, Florida, United States
Moffitt Cancer Center & Research Inst
Tampa, Florida, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
Washington University Medical Center
St Louis, Missouri, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon, France
...and 4 more locations
Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence.
Time frame: Baseline to Measured Progressive Disease (Up to 18 Months)
Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD. Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate.
Time frame: Baseline to Measured Progressive Disease (Up to 18 Months)
Percentage of Participants With Resectable Tumors (Resectability Rate)
Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions.
Time frame: Cycle 1 through Cycle 7 (Up to 6 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy
Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8
Time frame: Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle.
Time frame: Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion
Number of Participants With Anti-Olaratumab Antibodies
A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study.
Time frame: Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months)