LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma
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|ClinicalTrials.gov Identifier: NCT03287947|
Recruitment Status : Terminated (Low enrollment)
First Posted : September 19, 2017
Results First Posted : June 16, 2021
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Appendix Cancer||Drug: nintedanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm phase 2 study.|
|Masking:||None (Open Label)|
|Official Title:||LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma|
|Actual Study Start Date :||November 10, 2017|
|Actual Primary Completion Date :||September 3, 2019|
|Actual Study Completion Date :||October 27, 2019|
Oral nintedanib, taken twice daily
- Disease Control Rate [ Time Frame: From first dose of study drug to date of progression as determined by RECIST 1.1, assessed up to 7.5 months. ]The disease control rate is the proportion of those subjects with complete response, partial response, or stable disease, as defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Complete Response (CR), Disappearance of all target and non-target lesions, any pathological lymph nodes reduced in short axis to <10 mm; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor PD; Disease Control Rate (DCR) = CR + PR + SD.
- Overall Survival [ Time Frame: From date of first dose of study treatment to the date of death from any cause, assessed up to 14.5 months. ]Overall survival was defined as the duration from the start of nintedanib treatment to the date of death from any cause; subjects who are alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. Median overall survival was estimated using Kaplan-Meier methods. No formal comparative statistical analysis of overall survival was performed due to low accrual.
- Progression-free Survival [ Time Frame: From date of first dose of study treatment to the date of progressive disease or death from any cause, whichever occurred first, assessed up to 7.5 months. ]Progression-free survival was defined as the duration from the start of nintedanib treatment to the first occurrence of either progressive disease or death; disease progression was objectively determined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) or subjectively determined by the investigator. Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions (at least 5 mm), or a measurable increase or progression in a non-target lesion, or the appearance of new lesions. Median progression-free survival was estimated using Kaplan-Meier methods. No formal comparative statistical analysis of progression-free survival was performed due to low accrual.
- Treatment Administration of Nintedanib, as Measured by Average Daily Dose of Nintedanib. [ Time Frame: From the first dose of study drug to the last dose, assessed up to 7.5 months. ]The average daily dose of nintedanib is calculated as the total cumulative dose (in mg) of nintedanib administered divided by the number of 28-day cycles on nintedanib treatment. Prescribed daily dose of nintedanib is 400 mg.
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): NCT03287947
|United States, North Carolina|
|Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||Jimmy J Hwang, MD||Atrium Health|