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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)
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NDGA
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title NDGA
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
67.5
(55 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Prostate Specific Antigen (PSA) Response According to Consensus Criteria
Hide Description Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.
Time Frame Monthly, up to 29 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDGA
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
0
2.Post-Hoc Outcome
Title PSA Decline
Hide Description Number of participants experiencing PSA decline during the first 3 treatment cycles
Time Frame Baseline; Monthly, up to 29 months after beginning treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NDGA
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
7
3.Post-Hoc Outcome
Title Change in Prostate Specific Antigen Doubling Time (PSADT)
Hide Description PSADT was calculated using the formula natural log 2 divided by the slope of the natural log of the PSA versus time. Pretreatment PSADT was calculated using a minimum of 3 values; end of study PSADT incorporated all measured PSA values on study starting Cycle 2-Day 1 until the patient was removed from the study.
Time Frame Cycle 2 through end of treatment (up to 29 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
At the time of PSADT calculations, one participant was still on study at 29 months, and 11 participants' time on study had ranged from 2-19 months
Arm/Group Title NDGA
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: percentage change
17
(-66 to 72)
4.Post-Hoc Outcome
Title Disease Progression at End of Study
Hide Description End-of-study imaging was assessed for disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Progressive Disease (PD)=At least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Baseline, End of treatment (2-19 cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
At the time of calculation, 1 patient was still on study after 29 cycles
Arm/Group Title NDGA
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
0
Time Frame Monthly during study treatment, 2-33 months
Adverse Event Reporting Description Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
 
Arm/Group Title NDGA
Hide Arm/Group Description 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.
All-Cause Mortality
NDGA
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NDGA
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NDGA
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
Hyperglycemia  1  1/12 (8.33%)  1
Hypoalbuminemia  1  1/12 (8.33%)  1
Hypocalcemia  1  1/12 (8.33%)  1
Leukopenia  1  1/12 (8.33%)  1
Eye disorders   
Visual disturbance  1  1/12 (8.33%)  1
Gastrointestinal disorders   
Abdominal distension  1  3/12 (25.00%)  3
Diarrhea  1  12/12 (100.00%)  12
Dry mouth  1  1/12 (8.33%)  1
Gastritis  1  1/12 (8.33%)  1
Vomiting  1  1/12 (8.33%)  1
General disorders   
Elevated Alkaline phosphatase  1  2/12 (16.67%)  2
Fatigue  1  5/12 (41.67%)  5
Fever  1  1/12 (8.33%)  1
Headache  1  4/12 (33.33%)  4
Insomnia  1  1/12 (8.33%)  1
Myalgia  1  1/12 (8.33%)  1
Nausea  1  3/12 (25.00%)  3
Weight loss  1  1/12 (8.33%)  1
Hepatobiliary disorders   
Elevated ALT  1  8/12 (66.67%)  8
Elevated AST  1  6/12 (50.00%)  6
Elevated bilirubin  1  3/12 (25.00%)  3
Elevated CPK  1  1/12 (8.33%)  1
Elevated GGT  1  1/12 (8.33%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  1/12 (8.33%)  1
Nervous system disorders   
Syncope  1  1/12 (8.33%)  1
Psychiatric disorders   
Cognitive disturbance  1  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
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
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