Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01104155|
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 14, 2017
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: eribulin mesylate + erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer.|
|Actual Study Start Date :||February 24, 2010|
|Actual Primary Completion Date :||June 13, 2014|
|Actual Study Completion Date :||February 8, 2018|
|Active Comparator: eribulin mesylate, 21 day cycle||
Drug: eribulin mesylate + erlotinib
21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
|Active Comparator: eribulin mesylate, 28 day cycle||
Drug: eribulin mesylate + erlotinib
28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
- Objective Response Rate (ORR) [ Time Frame: From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011) ]ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)
- Duration of Response (DOR) [ Time Frame: From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years ]DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.
- Progression-Free Survival (PFS) [ Time Frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years ]PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.
- Disease Control Rate (DCR) [ Time Frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years ]DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)
- Overall Survival (OS) [ Time Frame: From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years ]OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104155
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|Study Director:||Eisai US Medical Services||Eisai Inc.|