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Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791336
Recruitment Status : Terminated (Poor enrollment.)
First Posted : November 14, 2008
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of Iowa

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Intervention Drug: Nelfinavir
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nelfinavir
Hide Arm/Group Description Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Nelfinavir
Hide Arm/Group Description Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Pathologic Complete Response
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).
Arm/Group Title Nelfinavir
Hide Arm/Group Description:
Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Characterization of Overall and Disease-free Survival
Hide Description [Not Specified]
Time Frame long-term
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).
Arm/Group Title Nelfinavir
Hide Arm/Group Description:
Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Safety and Tolerability of the Combined Treatment Regimen
Hide Description [Not Specified]
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).
Arm/Group Title Nelfinavir
Hide Arm/Group Description:
Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Collected through therapy (approximately 6 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nelfinavir
Hide Arm/Group Description Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
All-Cause Mortality
Nelfinavir
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Nelfinavir
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nelfinavir
Affected / at Risk (%)
Total   0/1 (0.00%) 
There was only one treated participant. Conclusions cannot be drawn from these data due to limited sampling size.
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: John M. Buatti, M.D., Chair, Department of Radiation Oncology
Organization: The University of Iowa
Phone: 319-356-2699
EMail: john-buatti@uiowa.edu
Layout table for additonal information
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00791336    
Other Study ID Numbers: 200802788
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: March 9, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017