A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor
Progenics Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01695044
Collaborator
(none)
119
36
1
29
3.3
0.1
Study Details
Study Description
Brief Summary
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
119 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer
Study Start Date
:
Sep 1, 2012
Actual Primary Completion Date
:
Oct 1, 2014
Actual Study Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: PSMA ADC Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
Drug: PSMA ADC
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Total Serum PSA Response [24 Weeks]
Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
- CTC Response [24 Weeks]
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%.
- Overall Radiologic Response [24 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A diagnosis of metastatic castration-resistant prostate cancer.
-
- Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.
OR
- No prior history of treatment with a cytotoxic chemotherapy regimen.
-
Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
-
Life expectancy ≥ six months.
-
Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.
Exclusion Criteria:
- Treatment within 30 days prior to first dose of study drug of the following:
-
External Radiation therapy
-
Radiopharmaceuticals
-
Cytotoxic chemotherapy
-
Treatment with an investigational agent
-
Clinically significant cardiac disease or severe debilitating pulmonary disease
-
An acute infection requiring ongoing antibiotic therapy
-
Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
-
History of drug and/or alcohol abuse
-
History of pancreatitis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35205 | |
| 2 | Tucson | Arizona | United States | 85724 | |
| 3 | Burbank | California | United States | 91505 | |
| 4 | Encinitas | California | United States | 92024 | |
| 5 | Los Angeles | California | United States | 90024 | |
| 6 | San Diego | California | United States | 92123 | |
| 7 | Denver | Colorado | United States | 80218 | |
| 8 | New Haven | Connecticut | United States | 06520 | |
| 9 | Norwalk | Connecticut | United States | 06856 | |
| 10 | Port St. Lucie | Florida | United States | 34952 | |
| 11 | Honolulu | Hawaii | United States | 96819 | |
| 12 | Fairway | Kansas | United States | 66205 | |
| 13 | New Orleans | Louisiana | United States | 70115 | |
| 14 | Baltimore | Maryland | United States | 21201 | |
| 15 | Baltimore | Maryland | United States | 21205 | |
| 16 | Rockville | Maryland | United States | 20850 | |
| 17 | Boston | Massachusetts | United States | 02111 | |
| 18 | Ann Arbor | Michigan | United States | 28109 | |
| 19 | Rochester | Minnesota | United States | 55905 | |
| 20 | Omaha | Nebraska | United States | 68130 | |
| 21 | Las Vegas | Nevada | United States | 89169 | |
| 22 | Lake Success | New York | United States | 11042 | |
| 23 | New York | New York | United States | 10065 | |
| 24 | Rochester | New York | United States | 14642 | |
| 25 | Stony Brook | New York | United States | 11794 | |
| 26 | Huntersville | North Carolina | United States | 28078 | |
| 27 | Raleigh | North Carolina | United States | 27607 | |
| 28 | Cleveland | Ohio | United States | 44195 | |
| 29 | Pittsburgh | Pennsylvania | United States | 15232 | |
| 30 | Providence | Rhode Island | United States | 02906 | |
| 31 | Greenville | South Carolina | United States | 29605 | |
| 32 | Myrtle Beach | South Carolina | United States | 29572 | |
| 33 | Memphis | Tennessee | United States | 38120 | |
| 34 | Dallas | Texas | United States | 75390 | |
| 35 | Norfolk | Virginia | United States | 23502 | |
| 36 | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Progenics Pharmaceuticals, Inc.
Investigators
- Study Director: Vivien Wong, PhD, Progenics Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01695044
Other Study ID Numbers:
- PSMA ADC 2301
First Posted:
Sep 27, 2012
Last Update Posted:
Mar 24, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1: PSMA ADC |
|---|---|
| Arm/Group Description | PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
| Period Title: Overall Study | |
| STARTED | 119 |
| COMPLETED | 17 |
| NOT COMPLETED | 102 |
Baseline Characteristics
| Arm/Group Title | Arm 1: PSMA ADC Chemotherapy-experienced | Arm 2: PSMA ADC Chemotherapy-naive | Total |
|---|---|---|---|
| Arm/Group Description | PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. | PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. | Total of all reporting groups |
| Overall Participants | 84 | 35 | 119 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
70.7
|
73.1
|
71.4
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
84
100%
|
35
100%
|
119
100%
|
| Prostate specific antigen (PSA) (ug/mL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [ug/mL] |
804.8
(2173.38)
|
220.9
(438.35)
|
633.1
(1857.2)
|
| PSA (ug/mL) [Median (Full Range) ] | |||
| Median (Full Range) [ug/mL] |
188.9
|
94.1
|
162.9
|
Outcome Measures
| Title | Percentage of Participants With Total Serum PSA Response |
|---|---|
| Description | Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%. |
| Time Frame | 24 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | PSMA ADC Chemotherapy-experienced | Chemotherapy-naive |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 79 | 34 |
| >30% Decrease in PSA |
29
|
32
|
| >50% Decrease in PSA |
11
|
21
|
| Title | CTC Response |
|---|---|
| Description | 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%. |
| Time Frame | 24 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | PSMA ADC Chemotherapy-experienced | Chemotherapy-naive |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 68 | 26 |
| >30% Decrease in CTC |
81
|
92
|
| >50% Decrease in CTC |
74
|
85
|
| Title | Overall Radiologic Response |
|---|---|
| Description | 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. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | PSMA ADC Chemotherapy-experienced | Chemotherapy-naive |
|---|---|---|
| Arm/Group Description | 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). | 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. |
| Measure Participants | 84 | 35 |
| Non-evaluable |
26
|
17
|
| Partial response |
0
|
6
|
| Progressive disease |
13
|
9
|
| Stable disease |
61
|
69
|
Adverse Events
| Time Frame | 24 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | PSMA ADC Chemotherapy-experienced | Chemotherapy-naive | ||
| Arm/Group Description | 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). | 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. | ||
All Cause Mortality |
||||
| PSMA ADC Chemotherapy-experienced | Chemotherapy-naive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PSMA ADC Chemotherapy-experienced | Chemotherapy-naive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 43/84 (51.2%) | 18/35 (51.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 4/84 (4.8%) | 0/35 (0%) | ||
| Febrile neutropenia | 2/84 (2.4%) | 3/35 (8.6%) | ||
| Neutropenia | 2/84 (2.4%) | 0/35 (0%) | ||
| Hemorrhagic anemia | 1/84 (1.2%) | 0/35 (0%) | ||
| Cardiac disorders | ||||
| Sinus tachycardia | 2/84 (2.4%) | 0/35 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/84 (3.6%) | 0/35 (0%) | ||
| Constipation | 2/84 (2.4%) | 2/35 (5.7%) | ||
| Ileus | 2/84 (2.4%) | 1/35 (2.9%) | ||
| General disorders | ||||
| Asthenia | 3/84 (3.6%) | 0/35 (0%) | ||
| Fatigue | 3/84 (3.6%) | 1/35 (2.9%) | ||
| Non-cardiac chest pain | 2/84 (2.4%) | 0/35 (0%) | ||
| Infections and infestations | ||||
| Bacteremia | 2/84 (2.4%) | 0/35 (0%) | ||
| Lobar pneumonia | 2/84 (2.4%) | 0/35 (0%) | ||
| Pneumonia | 3/84 (3.6%) | 0/35 (0%) | ||
| Sepsis | 2/84 (2.4%) | 1/35 (2.9%) | ||
| Investigations | ||||
| ECG QT prolonged | 2/84 (2.4%) | 0/35 (0%) | ||
| Decreased neutrophil count | 3/84 (3.6%) | 0/35 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 3/84 (3.6%) | 5/35 (14.3%) | ||
| Hyponatremia | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Hypophosphatemia | 2/84 (2.4%) | 1/35 (2.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/84 (2.4%) | 0/35 (0%) | ||
| Bone pain | 3/84 (3.6%) | 0/35 (0%) | ||
| Muscular weakness | 3/84 (3.6%) | 0/35 (0%) | ||
| Nervous system disorders | ||||
| Transient ischemic attack | 0/84 (0%) | 2/35 (5.7%) | ||
| Renal and urinary disorders | ||||
| Hematuria | 1/84 (1.2%) | 2/35 (5.7%) | ||
| Acute renal failure | 1/84 (1.2%) | 2/35 (5.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 4/84 (4.8%) | 0/35 (0%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 1/84 (1.2%) | 2/35 (5.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PSMA ADC Chemotherapy-experienced | Chemotherapy-naive | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 84/84 (100%) | 35/35 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 25/84 (29.8%) | 7/35 (20%) | ||
| Febrile neutropenia | 2/84 (2.4%) | 3/35 (8.6%) | ||
| Leukopenia | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Neutropenia | 16/84 (19%) | 6/35 (17.1%) | ||
| Cardiac disorders | ||||
| Tachycardia | 2/84 (2.4%) | 2/35 (5.7%) | ||
| Vertigo | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Eye disorders | ||||
| Vision blurred | 0/84 (0%) | 2/35 (5.7%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 41/84 (48.8%) | 23/35 (65.7%) | ||
| Diarrhea | 33/84 (39.3%) | 16/35 (45.7%) | ||
| Constipation | 30/84 (35.7%) | 12/35 (34.3%) | ||
| Vomiting | 22/84 (26.2%) | 12/35 (34.3%) | ||
| Abdominal pain | 15/84 (17.9%) | 5/35 (14.3%) | ||
| Dyspepsia | 7/84 (8.3%) | 6/35 (17.1%) | ||
| Abdominal pain upper | 5/84 (6%) | 0/35 (0%) | ||
| Dysphagia | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Flatulence | 4/84 (4.8%) | 2/35 (5.7%) | ||
| Gastroesophageal reflux disease | 8/84 (9.5%) | 1/35 (2.9%) | ||
| General disorders | ||||
| Fatigue | 52/84 (61.9%) | 19/35 (54.3%) | ||
| Peripheral edema | 18/84 (21.4%) | 4/35 (11.4%) | ||
| Asthenia | 13/84 (15.5%) | 3/35 (8.6%) | ||
| Pain | 9/84 (10.7%) | 3/35 (8.6%) | ||
| Chills | 4/84 (4.8%) | 2/35 (5.7%) | ||
| Gait disturbance | 5/84 (6%) | 2/35 (5.7%) | ||
| Pyrexia | 6/84 (7.1%) | 2/35 (5.7%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 9/84 (10.7%) | 4/35 (11.4%) | ||
| Upper resiratory tract infection | 2/84 (2.4%) | 2/35 (5.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 7/84 (8.3%) | 7/35 (20%) | ||
| Excoriation | 1/84 (1.2%) | 2/35 (5.7%) | ||
| Infusion related reaction | 5/84 (6%) | 1/35 (2.9%) | ||
| Investigations | ||||
| Aspartate aminotransferase increased | 18/84 (21.4%) | 1/35 (2.9%) | ||
| Decreased neutrophil count | 14/84 (16.7%) | 3/35 (8.6%) | ||
| Decreased weight | 14/84 (16.7%) | 8/35 (22.9%) | ||
| Alanine aminotransferase increased | 10/84 (11.9%) | 1/35 (2.9%) | ||
| White blood cell count decreased | 10/84 (11.9%) | 0/35 (0%) | ||
| Blood alkaline phosphatase increased | 8/84 (9.5%) | 1/35 (2.9%) | ||
| Lymphocyte count decreased | 5/84 (6%) | 0/35 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 40/84 (47.6%) | 15/35 (42.9%) | ||
| Dehydration | 20/84 (23.8%) | 6/35 (17.1%) | ||
| Hypophosphatemia | 15/84 (17.9%) | 2/35 (5.7%) | ||
| Hypokalemia | 14/84 (16.7%) | 11/35 (31.4%) | ||
| Hypocalcemia | 13/84 (15.5%) | 2/35 (5.7%) | ||
| Hyponatremia | 13/84 (15.5%) | 4/35 (11.4%) | ||
| Hyperglycemia | 12/84 (14.3%) | 2/35 (5.7%) | ||
| Hypoalbuminemia | 9/84 (10.7%) | 0/35 (0%) | ||
| Hypomagnesemia | 4/84 (4.8%) | 2/35 (5.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 19/84 (22.6%) | 11/35 (31.4%) | ||
| Back pain | 15/84 (17.9%) | 4/35 (11.4%) | ||
| Myalgia | 14/84 (16.7%) | 7/35 (20%) | ||
| Arthralgia | 10/84 (11.9%) | 4/35 (11.4%) | ||
| Bone pain | 10/84 (11.9%) | 4/35 (11.4%) | ||
| Musculoskeletal pain | 5/84 (6%) | 3/35 (8.6%) | ||
| Pain in extremity | 6/84 (7.1%) | 3/35 (8.6%) | ||
| Nervous system disorders | ||||
| Peripheral neuropathy | 31/84 (36.9%) | 13/35 (37.1%) | ||
| Headache | 17/84 (20.2%) | 3/35 (8.6%) | ||
| Dizziness | 11/84 (13.1%) | 6/35 (17.1%) | ||
| Peripheral sensory neuropathy | 7/84 (8.3%) | 8/35 (22.9%) | ||
| Dysgeusia | 5/84 (6%) | 6/35 (17.1%) | ||
| Ataxia | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Paraesthesia | 5/84 (6%) | 1/35 (2.9%) | ||
| Sciatica | 0/84 (0%) | 2/35 (5.7%) | ||
| Transient ischemic attack | 0/84 (0%) | 2/35 (5.7%) | ||
| Psychiatric disorders | ||||
| Insomnia | 18/84 (21.4%) | 6/35 (17.1%) | ||
| Depression | 3/84 (3.6%) | 5/35 (14.3%) | ||
| Anxiety | 5/84 (6%) | 3/35 (8.6%) | ||
| Confusional state | 5/84 (6%) | 1/35 (2.9%) | ||
| Renal and urinary disorders | ||||
| Hematuria | 4/84 (4.8%) | 2/35 (5.7%) | ||
| Proteinuria | 5/84 (6%) | 0/35 (0%) | ||
| Acute renal failure | 1/84 (1.2%) | 3/35 (8.6%) | ||
| Urinary incontinence | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 19/84 (22.6%) | 2/35 (5.7%) | ||
| Cough | 7/84 (8.3%) | 3/35 (8.6%) | ||
| Pleural effusion | 2/84 (2.4%) | 2/35 (5.7%) | ||
| Productive cough | 7/84 (8.3%) | 0/35 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 12/84 (14.3%) | 5/35 (14.3%) | ||
| Rash | 4/84 (4.8%) | 4/35 (11.4%) | ||
| Pruritus | 1/84 (1.2%) | 3/35 (8.6%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 3/84 (3.6%) | 2/35 (5.7%) | ||
| Hypertension | 2/84 (2.4%) | 2/35 (5.7%) | ||
| Hypotension | 5/84 (6%) | 2/35 (5.7%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Vincent A. DiPippo |
|---|---|
| Organization | Progenics Pharmaceuticals, Inc. |
| Phone | (646) 975-2502 |
| vdipippo@progenics.com |
Responsible Party:
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01695044
Other Study ID Numbers:
- PSMA ADC 2301
First Posted:
Sep 27, 2012
Last Update Posted:
Mar 24, 2017
Last Verified:
Feb 1, 2017