This study is a single institution Phase II single arm trial to assess the efficacy of the combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC (non-small cell lung cancer).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
25mg/m2 days 1, 3, 5
75mg/m2 day 1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
The Percentage of Patients That Respond to Treatment
Response is defined as either Partial Response or Complete Response. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Complete Response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
Time frame: Up to 2 Years
Median Progression Free Survival Time
Progression-free survival is defined as the duration of time from start of treatment to time of progression. Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time frame: Up to 2 Years
Median Overall Survival Time
Overall survival is defined as the duration of time from start of treatment to time of passing.
Time frame: Up to 2 Years
The Number of Patients Who Achieve Stable Disease
Stable disease rate will be reported as the count and proportion of patients who achieve stable disease. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started.
Time frame: Up to 2 Years
The Number of Toxicities by System Organ Class
All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.
Time frame: up to 30 days post last study drug dose, patients were allowed to stay on study drug treatment until progression. Data was collected over 3.5 years.
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