This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer. A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
IV infusion administered on day 1 and 15 of every 28-day cycle
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Overall Response Rate
Percentage of patients whose best overall response is assessed as complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Disease Control Rate
Percentage of all treated patients whose best overall response was complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: From first dose of CTX-009 until treatment discontinuation (an average of 16 weeks)
Duration of Response
Time from the CT or MRI that first confirmed complete (CR) or partial response PR) to the CT or MRI that first confirmed progression of disease progression (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: CR: disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; PD = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From first date of complete or partial response to first date of disease progression or death (up to 15.4 weeks)
Progression-free Survival
Time from first dose of CTX-009 to progression of disease or death. Progression of diseases is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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Zangmeister Cancer Center
Columbus, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Time frame: From first dose of CTX-009 to disease progression or death (up to 5.8 months)
Overall Survival
Time from first dose of CTX-009 to death
Time frame: From first dose of CTX-009 to death (up to 17.8 months)
Incidence of Treatment-emergent Adverse Events (TEAEs) and Changes in Clinical Abnormalities
TEAE is defined by occurrence of an adverse event that started or worsened in severity on or after the first dose of CTX-009 through 30 days after the last dose of CTX-009. Change in clinical abnormalities is defined as an increase in abnormality grade in a laboratory result, vital sign, or ECG parameter from predose result to worst postdose result (graded according to the Common Terminology Criteria for Adverse Events v5.0 for all analytes except for brain natriuretic peptide and troponin subtypes, which are interpreted in reference to the laboratory reference range for each), a post-baseline potentially clinically significant vital sign abnormality, or a post-baseline potentially clinically significant ECG abnormality.
Time frame: From the first CTX-009 dose to 30 days after the last CTX-009 dose (average 20 weeks) for TEAEs, from the first CTX-009 dose to 60 days after the last CTX-009 dose (average 25 weeks) for lab tests, vital signs, and ECGs.