The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer (mCRC) after failure of at least 2 lines of standard treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Fort Wayne Medical Oncology Hematology
Fort Wayne, Indiana, United States
Progression Free Survival (PFS)
PFS is defined as the time from randomization until objective tumor progression or death. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.
Time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Overall Survival (OS)
Overall survival is defined as the time from randomization until death from any cause. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.
Time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Objective Response Rate (ORR)
ORR is defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.
Time frame: tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
Disease Control (DC)
Disease control is defined as CR or PR or Stable disease (SD) per RECIST version 1.1. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.
Time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Percentage of Patients With Grade 3 or Worse Adverse Events
Percentage of patients with grade 3 or worse adverse events.
Time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
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