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Trial record 29 of 128 for:    Adenoid Cystic Carcinoma

Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

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: NCT01065844
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : December 19, 2016
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Intervention Drug: Nelfinavir
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nelfinavir
Hide Arm/Group Description

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday

Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Adverse Event             5
Arm/Group Title Nelfinavir
Hide Arm/Group Description

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  80.0%
>=65 years
3
  20.0%
[1]
Measure Description: Age, in years, of study participants at consent
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
[1]
Measure Description: Self-reported gender at time of study enrollment
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Tumor Progression
Hide Description Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Time Frame Every 1 to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures
Arm/Group Title Nelfinavir
Hide Arm/Group Description:

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday

Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
Complete reponse (CR)
0
   0.0%
Partial response (PR)
0
   0.0%
Stable disease (SD)
7
  63.6%
Progressive disease (PD)
4
  36.4%
Time Frame Adverse event data collected from day 1 of nelfinavir therapy through 30 days after final nelfinavir dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nelfinavir
Hide Arm/Group Description

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday

All-Cause Mortality
Nelfinavir
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nelfinavir
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nelfinavir
Affected / at Risk (%) # Events
Total   5/15 (33.33%)    
Blood and lymphatic system disorders   
platelet count decreased  1 [1]  1/15 (6.67%)  1
Investigations   
Investigations - Other, liver enzymes increased, grade 3  1 [2]  2/15 (13.33%)  2
Metabolism and nutrition disorders   
hyponatremia, grade 4  1 [3]  1/15 (6.67%)  1
Nervous system disorders   
dizziness, grade 3  1 [4]  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
grade 3
[2]
Marked elevations across liver function tests considered severe (grade 3)
[3]
A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
[4]
A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking. Grade: Severe - limiting activities of daily life
Favorable selection criteria were used in study design. RECIST assessed at a median interval of 12 weeks - this difference in methods may have artificially prolonged the progression free survival observed in this study.
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: John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier: NCT01065844     History of Changes
Other Study ID Numbers: 200905704
First Submitted: February 8, 2010
First Posted: February 9, 2010
Results First Submitted: October 25, 2016
Results First Posted: December 19, 2016
Last Update Posted: October 9, 2019