Trial Outcomes & Findings for Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer (NCT NCT00918385)
NCT ID: NCT00918385
Last Updated: 2014-10-29
Results Overview
PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
During monotherapy ( at least 12 weeks)
Results posted on
2014-10-29
Participant Flow
Accrual open from January 2009 to July 2011 in these institutions: Dana Farber Cancer Institute, Duke Cancer Institute, MD Anderson Cancer Center, Oregon Health \& Science Univ, U of CA at San Francisco, U of Washington.
64 consented, 7 screen failures. Of the 57 who began enrollment, 2 not assigned to treatment (withdrew consent, clinically unstable), 22 QC technical failures (received dasatinib off study) and 33 assigned per protocol (15 high AR, 18 low AR), 2 progressed before treatment. 14 high AR and 17 low AR began treatment and are included in the analysis.
Participant milestones
| Measure |
Arm 1=High AR Nilutamide
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
|---|---|---|
|
Monotherapy
STARTED
|
14
|
17
|
|
Monotherapy
COMPLETED
|
12
|
11
|
|
Monotherapy
NOT COMPLETED
|
2
|
6
|
|
Combination Nilutamide and Dasatinib
STARTED
|
12
|
11
|
|
Combination Nilutamide and Dasatinib
COMPLETED
|
6
|
3
|
|
Combination Nilutamide and Dasatinib
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Arm 1=High AR Nilutamide
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
|---|---|---|
|
Monotherapy
Adverse Event
|
1
|
6
|
|
Monotherapy
Complicating illness
|
1
|
0
|
|
Combination Nilutamide and Dasatinib
Adverse Event
|
1
|
1
|
|
Combination Nilutamide and Dasatinib
Withdrawal by Subject
|
2
|
7
|
|
Combination Nilutamide and Dasatinib
Complicating illness
|
1
|
0
|
Baseline Characteristics
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1=High AR Nilutamide
n=14 Participants
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
n=17 Participants
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During monotherapy ( at least 12 weeks)PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.
Outcome measures
| Measure |
Arm 1=High AR Nilutamide
n=14 Participants
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
n=17 Participants
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.8 months
Interval 2.7 to 4.4
|
2.6 months
Interval 1.1 to 3.0
|
SECONDARY outcome
Timeframe: During monotherapy (at least 12 weeks)Population: 14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided.
Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm 1=High AR Nilutamide
n=13 Participants
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
|---|---|---|
|
Overall Response Rate of Men With High AR Activity
|
0 percentage of patients with CR,PR
Interval 0.0 to 23.0
|
—
|
SECONDARY outcome
Timeframe: During dasatinib monotherapy ( at least 12 weeks)Population: Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans).
Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm 1=High AR Nilutamide
n=15 Participants
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
|---|---|---|
|
Overall Response Rate of Men With Low AR Activity
|
0 percentage of patients with CR,PR
Interval 0.0 to 21.0
|
—
|
Adverse Events
Arm 1=High AR Nilutamide
Serious events: 14 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2= Low AR Dasatinib
Serious events: 16 serious events
Other events: 1 other events
Deaths: 0 deaths
Combination Nilutamide and Dasatinib
Serious events: 14 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1=High AR Nilutamide
n=14 participants at risk
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
n=17 participants at risk
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
Combination Nilutamide and Dasatinib
n=23 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
78.6%
11/14
|
64.7%
11/17
|
56.5%
13/23
|
|
Blood and lymphatic system disorders
Lymph node pain
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Eye disorders
Blurred vision
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Eye disorders
Dry eye
|
0.00%
0/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Eye disorders
Eye disorders - Other
|
64.3%
9/14
|
0.00%
0/17
|
21.7%
5/23
|
|
Eye disorders
Eye pain
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14
|
11.8%
2/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14
|
35.3%
6/17
|
30.4%
7/23
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
4/14
|
23.5%
4/17
|
17.4%
4/23
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Fecal incontinence
|
14.3%
2/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14
|
11.8%
2/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.1%
1/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Nausea
|
71.4%
10/14
|
35.3%
6/17
|
30.4%
7/23
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14
|
17.6%
3/17
|
8.7%
2/23
|
|
General disorders
Edema limbs
|
28.6%
4/14
|
23.5%
4/17
|
4.3%
1/23
|
|
General disorders
Edema trunk
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Fatigue
|
28.6%
4/14
|
64.7%
11/17
|
43.5%
10/23
|
|
General disorders
Fever
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Flu like symptoms
|
7.1%
1/14
|
0.00%
0/17
|
4.3%
1/23
|
|
General disorders
Pain
|
42.9%
6/14
|
23.5%
4/17
|
8.7%
2/23
|
|
Infections and infestations
Gum infection
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Investigations
Creatinine increased
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14
|
23.5%
4/17
|
0.00%
0/23
|
|
Investigations
Platelet count decreased
|
7.1%
1/14
|
17.6%
3/17
|
8.7%
2/23
|
|
Investigations
Weight loss
|
0.00%
0/14
|
5.9%
1/17
|
13.0%
3/23
|
|
Investigations
White blood cell decreased
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14
|
41.2%
7/17
|
26.1%
6/23
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
|
17.6%
3/17
|
17.4%
4/23
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
3/14
|
11.8%
2/17
|
8.7%
2/23
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
7.1%
1/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
42.9%
6/14
|
29.4%
5/17
|
17.4%
4/23
|
|
Nervous system disorders
Ataxia
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Nervous system disorders
Cognitive disturbance
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
21.4%
3/14
|
11.8%
2/17
|
8.7%
2/23
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
|
0.00%
0/17
|
21.7%
5/23
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
0.00%
0/17
|
8.7%
2/23
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14
|
17.6%
3/17
|
13.0%
3/23
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14
|
0.00%
0/17
|
8.7%
2/23
|
|
Psychiatric disorders
Depression
|
14.3%
2/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
|
11.8%
2/17
|
8.7%
2/23
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14
|
11.8%
2/17
|
4.3%
1/23
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
14.3%
2/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14
|
5.9%
1/17
|
8.7%
2/23
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
2/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
2/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
2/14
|
11.8%
2/17
|
13.0%
3/23
|
|
Reproductive system and breast disorders
Scrotal pain
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14
|
5.9%
1/17
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14
|
17.6%
3/17
|
13.0%
3/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
1/14
|
0.00%
0/17
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14
|
11.8%
2/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
14.3%
2/14
|
5.9%
1/17
|
17.4%
4/23
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14
|
11.8%
2/17
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.4%
3/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Vascular disorders
Hot flashes
|
28.6%
4/14
|
5.9%
1/17
|
4.3%
1/23
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/14
|
0.00%
0/17
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
Other adverse events
| Measure |
Arm 1=High AR Nilutamide
n=14 participants at risk
High Androgen Receptor (AR) activity of \>= 0.50
Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle.
|
Arm 2= Low AR Dasatinib
n=17 participants at risk
Low Androgen Receptor (AR) activity of \< 0.50
Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle.
|
Combination Nilutamide and Dasatinib
n=23 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14
|
5.9%
1/17
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Renal and urinary disorders
Obstruction, GU:Ureter
|
7.1%
1/14
|
0.00%
0/17
|
0.00%
0/23
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/14
|
0.00%
0/17
|
4.3%
1/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place