Trial Outcomes & Findings for A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (NCT NCT01331083)
NCT ID: NCT01331083
Last Updated: 2023-08-22
Results Overview
Proportion of patients without evidence of progression (objective progression, defined as an increase in sum of diameters of target lesions of at least 20% above the lowest (or baseline) value (minimum of 5 mm increase) OR the appearance of unequivocal increase in non-measurable/non-target disease OR the appearance of new lesions, or PSA progression, defined as a rise in PSA of 25% (minimum 5 ng/ml) above baseline value or nadir, whichever is lowest, and confirmed by a second increasing value at least 3 weeks later) at 12 weeks after start of therapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Group A
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
25
|
|
Overall Study
COMPLETED
|
43
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Group A
n=43 Participants
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 Participants
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
72 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
43 participants
n=5 Participants
|
25 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All patients enrolled
Proportion of patients without evidence of progression (objective progression, defined as an increase in sum of diameters of target lesions of at least 20% above the lowest (or baseline) value (minimum of 5 mm increase) OR the appearance of unequivocal increase in non-measurable/non-target disease OR the appearance of new lesions, or PSA progression, defined as a rise in PSA of 25% (minimum 5 ng/ml) above baseline value or nadir, whichever is lowest, and confirmed by a second increasing value at least 3 weeks later) at 12 weeks after start of therapy
Outcome measures
| Measure |
Group A
n=43 Participants
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 Participants
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Lack of Disease Progression at 12 Weeks
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 weeksProportion of patients with PSA response defined as a \> 50% fall in PSA (minimum of 5 ng/ml) from baseline maintained for \> 4 weeks without evidence of disease progression otherwise
Outcome measures
| Measure |
Group A
n=43 Participants
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 Participants
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
PSA Response Rate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients enrolled
Proportion of patients with objective response defined as 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks
Outcome measures
| Measure |
Group A
n=43 Participants
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 Participants
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Objective Response Rate
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients with CTC assessed (not required for Group B patients)
Proportion of patients with Favorable circulating tumour cell (CTC) conversion (\< 5 CTC/7.5 mL)
Outcome measures
| Measure |
Group A
n=25 Participants
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Change in Circulating Tumour Cell Number During Treatment
|
6 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 8 serious events
Other events: 43 other events
Deaths: 6 deaths
Group B
Serious events: 5 serious events
Other events: 25 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Group A
n=43 participants at risk
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 participants at risk
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
3/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
2/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Lung infection
|
4.7%
2/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
4.7%
2/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Esophageal obstruction
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
4.7%
2/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.3%
1/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
General disorders
Fever
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
General disorders
Pain
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/43 • 6 months
|
4.0%
1/25 • 6 months
|
Other adverse events
| Measure |
Group A
n=43 participants at risk
Patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease, treated by PX-866 at 8mg when given orally daily
|
Group B
n=25 participants at risk
Patients with castration resistant prostate cancer, who have had PSA progression while receiving abiraterone/prednisonee, treated by PX-866 at 8mg when given orally daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.6%
8/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/43 • 6 months
|
8.0%
2/25 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
44.2%
19/43 • 6 months
|
56.0%
14/25 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
72.1%
31/43 • 6 months
|
72.0%
18/25 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
20.9%
9/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.0%
3/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
76.7%
33/43 • 6 months
|
52.0%
13/25 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
14/43 • 6 months
|
44.0%
11/25 • 6 months
|
|
General disorders
Chills
|
7.0%
3/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
General disorders
Edema limbs
|
18.6%
8/43 • 6 months
|
24.0%
6/25 • 6 months
|
|
General disorders
Fatigue
|
69.8%
30/43 • 6 months
|
84.0%
21/25 • 6 months
|
|
General disorders
Fever
|
7.0%
3/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
General disorders
Pain
|
32.6%
14/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Infections and infestations
Other infections and infestations
|
14.0%
6/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
48.8%
21/43 • 6 months
|
48.0%
12/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
51.2%
22/43 • 6 months
|
56.0%
14/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.0%
6/43 • 6 months
|
32.0%
8/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.0%
3/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.0%
6/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.3%
4/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.3%
4/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
39.5%
17/43 • 6 months
|
24.0%
6/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder
|
9.3%
4/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Nervous system disorders
Dysgeusia
|
9.3%
4/43 • 6 months
|
20.0%
5/25 • 6 months
|
|
Nervous system disorders
Headache
|
23.3%
10/43 • 6 months
|
28.0%
7/25 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.3%
10/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Psychiatric disorders
Depression
|
7.0%
3/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Psychiatric disorders
Insomnia
|
18.6%
8/43 • 6 months
|
8.0%
2/25 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
11.6%
5/43 • 6 months
|
8.0%
2/25 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
37.2%
16/43 • 6 months
|
24.0%
6/25 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
7.0%
3/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
18.6%
8/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • 6 months
|
20.0%
5/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
6/43 • 6 months
|
20.0%
5/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.3%
4/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Vascular disorders
Hot flashes
|
23.3%
10/43 • 6 months
|
28.0%
7/25 • 6 months
|
|
Vascular disorders
Hypertension
|
7.0%
3/43 • 6 months
|
4.0%
1/25 • 6 months
|
|
Vascular disorders
Hypotension
|
7.0%
3/43 • 6 months
|
0.00%
0/25 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
2.3%
1/43 • 6 months
|
20.0%
5/25 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Investigations
Weight loss
|
2.3%
1/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43 • 6 months
|
16.0%
4/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.3%
1/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
4.7%
2/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/43 • 6 months
|
12.0%
3/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43 • 6 months
|
8.0%
2/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/43 • 6 months
|
8.0%
2/25 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • 6 months
|
12.0%
3/25 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place