Trial Outcomes & Findings for Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer (NCT NCT00678015)
NCT ID: NCT00678015
Last Updated: 2014-04-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Monthly, up to 29 months
Results posted on
2014-04-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
NDGA
n=12 Participants
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.
|
|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Monthly, up to 29 monthsParticipants 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.
Outcome measures
| Measure |
NDGA
n=12 Participants
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.
|
|---|---|
|
Prostate Specific Antigen (PSA) Response According to Consensus Criteria
|
0 participants
|
POST_HOC outcome
Timeframe: Baseline; Monthly, up to 29 months after beginning treatmentNumber of participants experiencing PSA decline during the first 3 treatment cycles
Outcome measures
| Measure |
NDGA
n=12 Participants
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.
|
|---|---|
|
PSA Decline
|
7 participants
|
POST_HOC outcome
Timeframe: Cycle 2 through end of treatment (up to 29 months)Population: 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
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.
Outcome measures
| Measure |
NDGA
n=12 Participants
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.
|
|---|---|
|
Change in Prostate Specific Antigen Doubling Time (PSADT)
|
17 percentage change
Interval -66.0 to 72.0
|
POST_HOC outcome
Timeframe: Baseline, End of treatment (2-19 cycles)Population: At the time of calculation, 1 patient was still on study after 29 cycles
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.
Outcome measures
| Measure |
NDGA
n=11 Participants
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.
|
|---|---|
|
Disease Progression at End of Study
|
0 participants
|
Adverse Events
NDGA
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NDGA
n=12 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
3/12 • Number of events 3 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Psychiatric disorders
Cognitive disturbance
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
12/12 • Number of events 12 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Elevated Alkaline phosphatase
|
16.7%
2/12 • Number of events 2 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Headache
|
33.3%
4/12 • Number of events 4 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Nausea
|
25.0%
3/12 • Number of events 3 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Eye disorders
Visual disturbance
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
General disorders
Weight loss
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Hepatobiliary disorders
Elevated ALT
|
66.7%
8/12 • Number of events 8 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Hepatobiliary disorders
Elevated AST
|
50.0%
6/12 • Number of events 6 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Hepatobiliary disorders
Elevated bilirubin
|
25.0%
3/12 • Number of events 3 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Hepatobiliary disorders
Elevated CPK
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
|
Hepatobiliary disorders
Elevated GGT
|
8.3%
1/12 • Number of events 1 • Monthly during study treatment, 2-33 months
Patients were evaluated monthly for toxicity, which was graded according to common toxicity criteria (CTC) 3.0
|
Additional Information
Dr. Terence Friedlander
University of California, San Francisco
Phone: 415-353-7171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place