Trial Outcomes & Findings for An Open-label Extension Study of PSMA ADC 2301 in mCRPC (NCT NCT02020135)
NCT ID: NCT02020135
Last Updated: 2017-03-24
Results Overview
Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
25 Weeks
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
Arm 1: PSMA ADC
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
Baseline characteristics by cohort
| Measure |
PSMA ADC Chemotherapy-experienced
n=6 Participants
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
|
PSMA ADC Chemotherapy-naive
n=3 Participants
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
n=5 Participants
|
77.3 years
n=7 Participants
|
74.6 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
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Prostate specific antigen (PSA)
|
1446.3 ug/mL
STANDARD_DEVIATION 2209.9 • n=5 Participants
|
91.3 ug/mL
STANDARD_DEVIATION 125.8 • n=7 Participants
|
994.6 ug/mL
STANDARD_DEVIATION 1874.9 • n=5 Participants
|
|
PSA
|
442.2 ug/mL
n=5 Participants
|
32.1 ug/mL
n=7 Participants
|
221.2 ug/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 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 PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.
Outcome measures
| Measure |
PSMA ADC Chemotherapy-experienced
n=6 Participants
The chemotherapy-experienced group was comprised of 6 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).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
PSMA ADC Chemotherapy-naive
n=3 Participants
The chemotherapy-naïve group was comprised of 3 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.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
|---|---|---|
|
Percentage of Participants With Total Serum PSA Response
>30% Decrease in PSA
|
67 % of responders
|
33 % of responders
|
|
Percentage of Participants With Total Serum PSA Response
>50% Decrease in PSA
|
33 % of responders
|
0 % of responders
|
PRIMARY outcome
Timeframe: 25 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 measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.
Outcome measures
| Measure |
PSMA ADC Chemotherapy-experienced
n=5 Participants
The chemotherapy-experienced group was comprised of 6 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).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
PSMA ADC Chemotherapy-naive
n=2 Participants
The chemotherapy-naïve group was comprised of 3 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.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
|---|---|---|
|
CTC Response
|
100 % of responders
|
50 % of responders
|
PRIMARY outcome
Timeframe: 25 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). All subjects (n=9) enrolled in 2301EXT were evaluated.
Overall radiologic response was measured at baseline and post-baseline. 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=6 Participants
The chemotherapy-experienced group was comprised of 6 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).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
PSMA ADC Chemotherapy-naive
n=3 Participants
The chemotherapy-naïve group was comprised of 3 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.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
|---|---|---|
|
Overall Radiologic Response
Partial response
|
17 % of subjects
|
0 % of subjects
|
|
Overall Radiologic Response
Stable disease
|
83 % of subjects
|
100 % of subjects
|
Adverse Events
PSMA ADC Chemotherapy-experienced
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PSMA ADC Chemotherapy-naive
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PSMA ADC Chemotherapy-experienced
n=6 participants at risk
The chemotherapy-experienced group was comprised of 6 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).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
PSMA ADC Chemotherapy-naive
n=3 participants at risk
The chemotherapy-naïve group was comprised of 3 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.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
Other adverse events
| Measure |
PSMA ADC Chemotherapy-experienced
n=6 participants at risk
The chemotherapy-experienced group was comprised of 6 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).
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
PSMA ADC Chemotherapy-naive
n=3 participants at risk
The chemotherapy-naïve group was comprised of 3 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.
Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Cardiac disorders
Arrythmia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 25 weeks
|
66.7%
2/3 • 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
General disorders
Asthenia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
General disorders
Fatigue
|
33.3%
2/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
General disorders
Gravitational edema
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
General disorders
Chills
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
General disorders
Peripheral edema
|
16.7%
1/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
General disorders
Pain
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Investigations
Weight decreased
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Nervous system disorders
Balance disorder
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 25 weeks
|
66.7%
2/3 • 25 weeks
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Nervous system disorders
Peripheral neuropathy
|
100.0%
6/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 25 weeks
|
33.3%
1/3 • 25 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • 25 weeks
|
0.00%
0/3 • 25 weeks
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • 25 weeks
|
0.00%
0/3 • 25 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