entinostat and Local Neoplasm Recurrence

entinostat has been researched along with Local Neoplasm Recurrence in 9 studies

Research

Studies (9)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants with overall response (CR + PR) plus stable disease (SD) for 6 months as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR 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. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00676663)
Timeframe: From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months)

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with response during treatment classified as complete response (CR) or partial response (PR), as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR 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. (NCT00676663)
Timeframe: From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months)

Overall Survival (OS)

OS was defined as the number of months elapsed between the date of randomization and the date of death (whatever the cause). (NCT00676663)
Timeframe: First dose of study drug to end of study (Median follow-up 24 months in the EE arm and 26.4 months in the EP arm)

Progression-free Survival (PFS)

PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause. (NCT00676663)
Timeframe: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

"An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs. A TEAE is an AE that starts after the administration of study drug.~A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard." (NCT00676663)
Timeframe: First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years)

Reviews

2 reviews available for entinostat and Local Neoplasm Recurrence

Trials

5 trials available for entinostat and Local Neoplasm Recurrence

Other Studies

2 other studies available for entinostat and Local Neoplasm Recurrence