Trial Outcomes & Findings for A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) (NCT NCT01695044)
NCT ID: NCT01695044
Last Updated: 2017-03-24
Results Overview
Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
24 Weeks
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
Arm 1: PSMA ADC
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
102
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
Arm 1: PSMA ADC Chemotherapy-experienced
n=84 Participants
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
|
Arm 2: PSMA ADC Chemotherapy-naive
n=35 Participants
PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 years
n=5 Participants
|
73.1 years
n=7 Participants
|
71.4 years
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
|
84 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Prostate specific antigen (PSA)
|
804.8 ug/mL
STANDARD_DEVIATION 2173.38 • n=5 Participants
|
220.9 ug/mL
STANDARD_DEVIATION 438.35 • n=7 Participants
|
633.1 ug/mL
STANDARD_DEVIATION 1857.2 • n=5 Participants
|
|
PSA
|
188.9 ug/mL
n=5 Participants
|
94.1 ug/mL
n=7 Participants
|
162.9 ug/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.
Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
Outcome measures
| Measure |
PSMA ADC Chemotherapy-experienced
n=79 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
|
Chemotherapy-naive
n=34 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
|
|---|---|---|
|
Percentage of Participants With Total Serum PSA Response
>50% Decrease in PSA
|
11 % of responders
|
21 % of responders
|
|
Percentage of Participants With Total Serum PSA Response
>30% Decrease in PSA
|
29 % of responders
|
32 % of responders
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.
Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.
Outcome measures
| Measure |
PSMA ADC Chemotherapy-experienced
n=68 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
|
Chemotherapy-naive
n=26 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
|
|---|---|---|
|
CTC Response
>30% Decrease in CTC
|
81 % of responders
|
92 % of responders
|
|
CTC Response
>50% Decrease in CTC
|
74 % of responders
|
85 % of responders
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined.
Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper \& lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.
Outcome measures
| Measure |
PSMA ADC Chemotherapy-experienced
n=84 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
|
Chemotherapy-naive
n=35 Participants
Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.
The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
|
|---|---|---|
|
Overall Radiologic Response
Partial response
|
0 % of subjects
|
6 % of subjects
|
|
Overall Radiologic Response
Progressive disease
|
13 % of subjects
|
9 % of subjects
|
|
Overall Radiologic Response
Stable disease
|
61 % of subjects
|
69 % of subjects
|
|
Overall Radiologic Response
Non-evaluable
|
26 % of subjects
|
17 % of subjects
|
Adverse Events
PSMA ADC Chemotherapy-experienced
Serious events: 43 serious events
Other events: 84 other events
Deaths: 0 deaths
Chemotherapy-naive
Serious events: 18 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PSMA ADC Chemotherapy-experienced
n=84 participants at risk
PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
|
Chemotherapy-naive
n=35 participants at risk
PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
4/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
2/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Hemorrhagic anemia
|
1.2%
1/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.4%
2/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Ileus
|
2.4%
2/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Asthenia
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
General disorders
Fatigue
|
3.6%
3/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Infections and infestations
Bacteremia
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Infections and infestations
Lobar pneumonia
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Infections and infestations
Sepsis
|
2.4%
2/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Investigations
ECG QT prolonged
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Investigations
Decreased neutrophil count
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
3/84 • 24 weeks
|
14.3%
5/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
2/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.6%
3/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Renal and urinary disorders
Hematuria
|
1.2%
1/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
1.2%
1/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
4/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
Other adverse events
| Measure |
PSMA ADC Chemotherapy-experienced
n=84 participants at risk
PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
|
Chemotherapy-naive
n=35 participants at risk
PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
29.8%
25/84 • 24 weeks
|
20.0%
7/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
2/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.0%
16/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Cardiac disorders
Tachycardia
|
2.4%
2/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Cardiac disorders
Vertigo
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
48.8%
41/84 • 24 weeks
|
65.7%
23/35 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
39.3%
33/84 • 24 weeks
|
45.7%
16/35 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
35.7%
30/84 • 24 weeks
|
34.3%
12/35 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
22/84 • 24 weeks
|
34.3%
12/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
15/84 • 24 weeks
|
14.3%
5/35 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
7/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
5/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
4/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.5%
8/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Fatigue
|
61.9%
52/84 • 24 weeks
|
54.3%
19/35 • 24 weeks
|
|
General disorders
Peripheral edema
|
21.4%
18/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
General disorders
Asthenia
|
15.5%
13/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
General disorders
Pain
|
10.7%
9/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
General disorders
Chills
|
4.8%
4/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
General disorders
Gait disturbance
|
6.0%
5/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
General disorders
Pyrexia
|
7.1%
6/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
10.7%
9/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Infections and infestations
Upper resiratory tract infection
|
2.4%
2/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
7/84 • 24 weeks
|
20.0%
7/35 • 24 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.2%
1/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.0%
5/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
18/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Decreased neutrophil count
|
16.7%
14/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Investigations
Decreased weight
|
16.7%
14/84 • 24 weeks
|
22.9%
8/35 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
10/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Investigations
White blood cell count decreased
|
11.9%
10/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
9.5%
8/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
6.0%
5/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.6%
40/84 • 24 weeks
|
42.9%
15/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
23.8%
20/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.9%
15/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
14/84 • 24 weeks
|
31.4%
11/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.5%
13/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.5%
13/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
12/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.7%
9/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.8%
4/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
22.6%
19/84 • 24 weeks
|
31.4%
11/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
15/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
14/84 • 24 weeks
|
20.0%
7/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
10/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.9%
10/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
5/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
6/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Nervous system disorders
Peripheral neuropathy
|
36.9%
31/84 • 24 weeks
|
37.1%
13/35 • 24 weeks
|
|
Nervous system disorders
Headache
|
20.2%
17/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
13.1%
11/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
7/84 • 24 weeks
|
22.9%
8/35 • 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
6.0%
5/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Nervous system disorders
Ataxia
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Nervous system disorders
Paraesthesia
|
6.0%
5/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
21.4%
18/84 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Psychiatric disorders
Depression
|
3.6%
3/84 • 24 weeks
|
14.3%
5/35 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
6.0%
5/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Psychiatric disorders
Confusional state
|
6.0%
5/84 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Renal and urinary disorders
Hematuria
|
4.8%
4/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Renal and urinary disorders
Proteinuria
|
6.0%
5/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
1.2%
1/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.6%
19/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
7/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
2/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
7/84 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
12/84 • 24 weeks
|
14.3%
5/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
4/84 • 24 weeks
|
11.4%
4/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
1/84 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
3.6%
3/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Vascular disorders
Hypertension
|
2.4%
2/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Vascular disorders
Hypotension
|
6.0%
5/84 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
Additional Information
Dr. Vincent A. DiPippo
Progenics Pharmaceuticals, Inc.
Phone: (646) 975-2502
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place