Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03228186|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Pevonedistat Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Experimental: Pevonedistat plus Docetaxel
Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
25mg/m2 days 1, 3, 5
Other Name: TAK-924
75mg/m2 day 1
- The percentage of patients that respond to treatment [ Time Frame: Up to 2 Years ]
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.
- Median Progression Free Survival Time [ Time Frame: Up to 2 Years ]
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.
- Median Overall Survival Time [ Time Frame: Up to 2 Years ]
- The number of patients who achieve stable disease [ Time Frame: Up to 2 Years ]
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.
- The number of toxicities by system organ class [ Time Frame: Up to 30 days post treatment ]All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228186
|Contact: Gregory Kalemkerian, M.D.||firstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48187|
|Contact: Gregory Kalemkerian, M.D. 734-647-8921 email@example.com|
|Principal Investigator: Gregory Kalemkerian, M.D.|
|Principal Investigator:||Gregory Kalemkerian, M.D.||University of Michigan Rogel Cancer Center|