Trial Outcomes & Findings for Satraplatin and Prednisone to Treat Prostate Cancer (NCT NCT00634647)
NCT ID: NCT00634647
Last Updated: 2018-10-02
Results Overview
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
15 months
Results posted on
2018-10-02
Participant Flow
Participant milestones
| Measure |
Satraplatin
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Satraplatin
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Overall Study
death on study
|
3
|
|
Overall Study
refused further treatment
|
3
|
|
Overall Study
declined to participate before treatment
|
1
|
Baseline Characteristics
Satraplatin and Prednisone to Treat Prostate Cancer
Baseline characteristics by cohort
| Measure |
Satraplatin
n=24 Participants
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
64.83 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: 24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest 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 |
Satraplatin
n=20 Participants
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Progression Free Survival.
|
6.0 Months
Interval 2.3 to 9.3
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 57 months.Population: The time frame for adverse events includes one year follow-up data.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Satraplatin
n=23 Participants
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
|
23 Participants
|
SECONDARY outcome
Timeframe: time between the first day of treatment to the day of death, approximately 15.7 monthsPopulation: 24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).
Overall Survival is the time between the first day of treatment to the day of death.
Outcome measures
| Measure |
Satraplatin
n=21 Participants
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Median Overall Survival (OS)
|
16.0 Months
Interval 6.5 to
The upper limit of the confidence interval was not reached because patients were on-study at the time data was analyzed.
|
Adverse Events
Satraplatin
Serious events: 11 serious events
Other events: 23 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Satraplatin
n=23 participants at risk
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Infections and infestations
Infection, Other (septic shock)
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Platelets
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Death
|
43.5%
10/23 • Number of events 10 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
Other adverse events
| Measure |
Satraplatin
n=23 participants at risk
satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
|
|---|---|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
17.4%
4/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
34.8%
8/23 • Number of events 9 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
34.8%
8/23 • Number of events 10 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Anorexia
|
26.1%
6/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum low
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
17.4%
4/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Nervous system disorders
Confusion
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Creatinine
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Dental: teeth
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Edema: limb
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
39.1%
9/23 • Number of events 9 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Flu-like syndrome
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (pain intermittent diarrhea)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.2%
15/23 • Number of events 25 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Endocrine disorders
Hot flashes/flushes
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Cardiac disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Cardiac disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder tract NOS
|
4.3%
1/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Insomnia
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
65.2%
15/23 • Number of events 38 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
60.9%
14/23 • Number of events 25 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
17.4%
4/23 • Number of events 4 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::oral cavity
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-Other, muscle cramping
|
4.3%
1/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
7/23 • Number of events 11 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Nervous system disorders
Neuropathy:sensory
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
52.2%
12/23 • Number of events 21 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Eye disorders
Ocular/Visual-Other, visual field deficit (blind spot)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Pain -Other,intermittent LE pain
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Pain-abdomen NOS
|
8.7%
2/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
8.7%
2/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
17.4%
4/23 • Number of events 7 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Blood and lymphatic system disorders
Platelets
|
78.3%
18/23 • Number of events 51 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
8.7%
2/23 • Number of events 2 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
26.1%
6/23 • Number of events 8 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Renal and urinary disorders
Renal failure
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
General disorders
Weight loss
|
13.0%
3/23 • Number of events 3 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
5/23 • Number of events 6 • Date treatment consent signed to date off study, approximately 57 months.
The time frame for adverse events includes one year follow-up data.
|
Additional Information
Dr. William Dahut
National Cancer Institute, National Institutes of Health
Phone: 301-435-8183
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place