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. Identifier: NCT00791336
Recruitment Status : Terminated (Poor enrollment.)
First Posted : November 14, 2008
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
University of Iowa

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Nelfinavir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Nelfinavir Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Nelfinavir Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   1 

  Outcome Measures

1.  Primary:   Pathologic Complete Response   [ Time Frame: 30 days ]

2.  Secondary:   Characterization of Overall and Disease-free Survival   [ Time Frame: long-term ]

3.  Secondary:   Safety and Tolerability of the Combined Treatment Regimen   [ Time Frame: 7 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was only one treated participant. Conclusions cannot be drawn from these data due to limited sampling size.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: John M. Buatti, M.D., Chair, Department of Radiation Oncology
Organization: The University of Iowa
phone: 319-356-2699

Responsible Party: University of Iowa Identifier: NCT00791336     History of Changes
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