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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
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Jimmy Hwang, Atrium Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Appendix Cancer
Intervention Drug: nintedanib
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nintedanib
Hide Arm/Group Description Participants received 200 mg oral nintedanib, taken twice daily.
Period Title: Overall Study
Started 5 [1]
Completed 5 [2]
Not Completed 0
[1]
Five subjects were enrolled to the study.
[2]
All subjects enrolled discontinued treatment and are now off study.
Arm/Group Title Nintedanib
Hide Arm/Group Description Subjects received 200 mg oral nintedanib, taken twice daily.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Five subjects enrolled to the study at their initiations of nintedanib therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
62.8  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  20.0%
White
4
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ascites present at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
1
  20.0%
1.Primary Outcome
Title Disease Control Rate
Hide Description 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.
Time Frame From first dose of study drug to date of progression as determined by RECIST 1.1, assessed up to 7.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled to the study at their initiations of nintedanib therapy and had measurable disease at baseline; four of five enrolled subjects had measurable disease at baseline.
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Subjects received 200 mg oral nintedanib, taken twice daily.
Overall Number of Participants Analyzed 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.25
(.0064 to .8058)
2.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame From date of first dose of study treatment to the date of death from any cause, assessed up to 14.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All five enrolled subjects are evaluable for the analysis of overall survival.
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Subjects received 200 mg oral nintedanib, taken twice daily.
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
2.62
(0.78 to 14.32)
3.Secondary Outcome
Title Progression-free Survival
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
All five enrolled subjects are evaluable for the analysis of progression-free survival.
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Subjects received 200 mg oral nintedanib, taken twice daily.
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
1.34
(0.75 to 7.29)
4.Secondary Outcome
Title Treatment Administration of Nintedanib, as Measured by Average Daily Dose of Nintedanib.
Hide Description 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.
Time Frame From the first dose of study drug to the last dose, assessed up to 7.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects returning bottles for drug accountability are included in the reporting of average daily dose of nintedanib.
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Subjects received 200 mg oral nintedanib, taken twice daily.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mg per cycle day
354.9  (48.4)
Time Frame Adverse event data was collected for subjects from enrollment until 30 days after last dose of study drug, assessed up to 8.5 months. All-Cause Mortality data was collected from enrollment until death, assessed up to 14.5 months.
Adverse Event Reporting Description The attribution and severity of adverse events were classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
 
Arm/Group Title Nintedanib
Hide Arm/Group Description Subjects received 200 mg oral nintedanib, taken twice daily.
All-Cause Mortality
Nintedanib
Affected / at Risk (%)
Total   5/5 (100.00%)    
Hide Serious Adverse Events
Nintedanib
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Cardiac disorders   
Cardiac arrest *  1/5 (20.00%)  1
Gastrointestinal disorders   
Duodenal obstruction *  1/5 (20.00%)  1
General disorders   
Death NOS *  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nintedanib
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Cardiac disorders   
Cardiac disorders - Other, Bradycardia   1/5 (20.00%)  1
Eye disorders   
Eye pain   1/5 (20.00%)  1
Gastrointestinal disorders   
Abdominal distension   1/5 (20.00%)  1
Abdominal pain   1/5 (20.00%)  1
Diarrhea   1/5 (20.00%)  1
Nausea   2/5 (40.00%)  3
Vomiting   2/5 (40.00%)  3
General disorders   
Fatigue   2/5 (40.00%)  2
Localized edema   1/5 (20.00%)  1
Infections and infestations   
Urinary tract infection   1/5 (20.00%)  1
Metabolism and nutrition disorders   
Anorexia   2/5 (40.00%)  2
Dehydration   1/5 (20.00%)  1
Hypokalemia   1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Myalgia   1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Dry skin   1/5 (20.00%)  1
Scalp pain   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danielle M Boselli
Organization: Atrium Health/Levine Cancer Institute, Department of Cancer Biostatistics
Phone: 12017903385
EMail: Danielle.Boselli@AtriumHealth.org
Layout table for additonal information
Responsible Party: Jimmy Hwang, Atrium Health
ClinicalTrials.gov Identifier: NCT03287947    
Other Study ID Numbers: LCI-GI-APX-NIN-001
00021617 ( Other Identifier: Advarra IRB )
First Submitted: July 31, 2017
First Posted: September 19, 2017
Results First Submitted: October 26, 2020
Results First Posted: June 16, 2021
Last Update Posted: June 16, 2021