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Trial record 16 of 17 for:    insmed

Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00678015
Recruitment Status : Terminated (Per protocol - interim analysis showed no significant PSA declines among the first 12 patients after 3 cycles of treatment)
First Posted : May 15, 2008
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Insmed Incorporated
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Nordihydroguaiaretic Acid (NDGA)

  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
  Description
NDGA Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.

Participant Flow:   Overall Study
    NDGA
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  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
  Description
NDGA Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.

Baseline Measures
   NDGA 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Median (Full Range)
 67.5 
 (55 to 86) 
Gender 
[Units: Participants]
 
Female   0 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Prostate Specific Antigen (PSA) Response According to Consensus Criteria   [ Time Frame: Monthly, up to 29 months ]

2.  Post-Hoc:   PSA Decline   [ Time Frame: Baseline; Monthly, up to 29 months after beginning treatment ]

3.  Post-Hoc:   Change in Prostate Specific Antigen Doubling Time (PSADT)   [ Time Frame: Cycle 2 through end of treatment (up to 29 months) ]

4.  Post-Hoc:   Disease Progression at End of Study   [ Time Frame: Baseline, End of treatment (2-19 cycles) ]


  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
Per protocol - accrual was stopped early after a pre-planned interim analysis showed no significant PSA declines after 3 cycles of treatment among the first 12 patients enrolled.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Terence Friedlander
Organization: University of California, San Francisco
phone: 415-353-7171
e-mail: terence.friedlander@ucsf.edu


Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00678015     History of Changes
Other Study ID Numbers: 075511
First Submitted: May 12, 2008
First Posted: May 15, 2008
Results First Submitted: January 28, 2014
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014